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{{Short description|Biopharmaceutical drug}}
'''CNTO 1275''' is the experimental name for a human immunosuppressive drug developed by the biotechnology company [[Centocor]]. It is a laboratory-manufactured, [[Monoclonal antibodies|monoclonal antibody]] directed against [[interleukin]]s [[IL-12]] and [[IL-23]] and presently undergoing [[clinical trial]]s to determine its safety and effectiveness against the diseases [[Multiple Sclerosis]], [[Psoriasis]], and [[Psoriatic Arthritis]].
{{Use dmy dates|date=July 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 470627281
| type = mab
| image =
| width =
| alt =
| caption =


<!-- Monoclonal antibody data -->
Once released for public use, administration and dosage of the drug will most likely by doctor's prescription and direction only.
| mab_type = mab
| source = u
| target = [[Interleukin 12|IL-12]] and [[Interleukin 23|IL-23]]


<!-- Clinical data -->
| pronounce =
| tradename = Stelara
| Drugs.com = {{drugs.com|monograph|ustekinumab}}
| MedlinePlus = a611013
| DailyMedID = Ustekinumab
| pregnancy_AU = B1
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Ustekinumab (Stelara) Use During Pregnancy | website=Drugs.com | date=26 November 2019 | url=https://www.drugs.com/pregnancy/ustekinumab.html | access-date=6 April 2020 | archive-date=22 May 2020 | archive-url=https://web.archive.org/web/20200522084941/https://www.drugs.com/pregnancy/ustekinumab.html | url-status=live }}</ref><ref name="Wezlana APMDS" />
| pregnancy_category =
| routes_of_administration = [[Subcutaneous injection|Subcutaneous]], [[intravenous]]
| class = [[Immunosuppressant interleukin inhibitor]]
| ATC_prefix = L04
| ATC_suffix = AC05
| ATC_supplemental =
| biosimilars = ustekinumab-aauz,<ref name="Otulfi FDA label" /> ustekinumab-aekn,<ref name="Selarsdi PR">{{cite press release | title=Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab) | publisher=Alvotech | via=GlobeNewswire | date=16 April 2024 | url=https://www.globenewswire.com/news-release/2024/04/16/2864156/0/en/Alvotech-and-Teva-Announce-U-S-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab.html | access-date=17 April 2024 | archive-date=17 April 2024 | archive-url=https://web.archive.org/web/20240417034634/https://www.globenewswire.com/news-release/2024/04/16/2864156/0/en/Alvotech-and-Teva-Announce-U-S-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab.html | url-status=live }}</ref> ustekinumab-auub,<ref name="FDA Wezlana press release" /> ustekinumab-kfce,<ref name="Yesintek PR" /> ustekinumab-srlf,<ref name="Imuldosa PR 20241014" /> ustekinumab-stba,<ref name="Steqeyma FDA label" /> ustekinumab-ttwe,<ref name="Pyzchiva FDA label" /> Eksunbi,<ref name="Eksunbi EPAR" /><ref name="Eksunbi PI" /> Fymskina,<ref name="Fymskina EPAR" /><ref name="Fymskina PI" /> Imuldosa,<ref name="Imuldosa PR 20241014" /> Jamteki,<ref name="Jamteki CA SBD" /> Otulfi,<ref name="Otulfi FDA label" /><ref name="Otulfi EPAR" /><ref name="Otulfi PI" /> Pyzchiva,<ref name="Pyzchiva FDA label" /><ref name="Pyzchiva EPAR" /><ref name="Pyzchiva PI" /> Selarsdi,<ref name="Selarsdi PR" /> Steqeyma,<ref name="Steqeyma EPAR" /><ref name="Steqeyma PI" /> Uzpruvo,<ref name="Uzpruvo EPAR" /> Wezlana,<ref name="FDA Wezlana press release" /><ref name="Wezlana APMDS" /> Wezenla,<ref name="Wezenla EPAR" /><ref name="Wezenla PI" /> Yesintek<ref name="Yesintek PR" />


<!-- Legal status -->
==Development==
| legal_AU = S4
| legal_AU_comment = <ref name="Wezlana APMDS">{{cite web | title=Wezlana APMDS | website=Therapeutic Goods Administration (TGA) | date=30 January 2024 | url=https://www.tga.gov.au/resources/auspmd/wezlana | access-date=7 March 2024 | archive-date=8 February 2024 | archive-url=https://web.archive.org/web/20240208064947/https://www.tga.gov.au/resources/auspmd/wezlana | url-status=live }}</ref><ref>{{cite web | title=Prescription medicines and biologicals: TGA annual summary 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-tga-annual-summary-2017 | access-date=31 March 2024 | archive-date=31 March 2024 | archive-url=https://web.archive.org/web/20240331021323/https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-tga-annual-summary-2017 | url-status=live }}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Regulatory Decision Summary for Stelara | website=[[Health Canada]] | date=16 June 2020 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00665 | access-date=28 August 2024}}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment = <ref name="Stelara SmPC">{{cite web | title=Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC) | website=(emc) | date=27 February 2020 | url=https://www.medicines.org.uk/emc/product/4413/smpc | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183107/https://www.medicines.org.uk/emc/product/4413/smpc | url-status=live }}</ref>
| legal_US = Rx-only
| legal_US_comment = <ref name="Stelara FDA label" />
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Stelara EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = Rx-only


<!-- Pharmacokinetic data -->
As of January 2007, there were 5 NIH-listed research studies involving CNTO 1275 on a multinational basis, including 3 Phase II and 2 Phase III trials. Three studies are focused on patients with psoriasis, one on psoriatic arthritis, and one on Multiple Sclerosis.
| bioavailability =
| protein_bound =
| metabolism = unknown<ref name="Stelara SmPC" />
| metabolites =
| onset =
| elimination_half-life = 15–32 days (average 3 weeks)<ref name="Stelara SmPC" />
| duration_of_action =
| excretion =


<!-- Identifiers -->
CNTO 1275 is not yet [[Approved_drug|approved]] by the [[Food and Drug Administration|U.S. Food and Drug Administration]].
| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 815610-63-0
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB05679
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = FU77B4U5Z0
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D09214
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201835
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = CNTO 1275


<!-- Chemical and physical data -->
On December 4, 2007 Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) was filed by Centocor and Janssen-Cilag International (collaborator) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA).
| IUPAC_name =
| C=6482 | H=10004 | N=1712 | O=2016 | S=46
| SMILES =
| StdInChI =
| StdInChI_comment =
| StdInChIKey =
| density =
| density_notes =
| melting_point =
| melting_high =
| melting_notes =
| boiling_point =
| boiling_notes =
| solubility =
| sol_units =
| specific_rotation =
}}


'''Ustekinumab''', sold under the brand name '''Stelara''' among others, is a [[monoclonal antibody]] medication used for the treatment of [[Crohn's disease]], [[ulcerative colitis]], [[Psoriasis|plaque psoriasis]] and [[psoriatic arthritis]],<ref name="AHFS2017" /> targeting both IL-12 and IL-23.<ref>{{cite journal | vauthors = Cingoz O | title = Ustekinumab | journal = mAbs | volume = 1 | issue = 3 | pages = 216–221 | year = 2009 | pmid = 20069753 | pmc = 2726595 | doi = 10.4161/mabs.1.3.8593 }}</ref> It is administered either by [[intravenous infusion]] or [[subcutaneous injection]].<ref name="AHFS2017" /> The antibody targets a subunit of human [[interleukin 12]] and [[interleukin 23]], which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.<ref name="pmid17761156">{{cite journal | vauthors = Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U | title = Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275 | journal = Cellular Immunology | volume = 247 | issue = 1 | pages = 1–11 | date = May 2007 | pmid = 17761156 | doi = 10.1016/j.cellimm.2007.06.006 }}</ref> Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells.<ref name="Yesintek EPAR" /> By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease.<ref name="Yesintek EPAR" /> Ustekinumab was developed by Centocor Ortho Biotech.<ref name="Stelara approval package" />
==Delivery==


Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union; and ulcerative colitis in the United States, and in the European Union to people who have not responded to more traditional treatments.<ref name="Stelara FDA label" /><ref name="Stelara EPAR" /><ref name="healio.com">{{cite web|title=EC approves expanded use of Stelara for moderately to severely active ulcerative colitis|url=https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B1092e4c0-15b5-4ba2-871b-3a7930e27283%7D/ec-approves-expanded-use-of-stelara-for-moderately-to-severely-active-ulcerative-colitis|access-date=26 September 2019|website=Healio.com|archive-date=9 September 2019|archive-url=https://web.archive.org/web/20190909060817/https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B1092e4c0-15b5-4ba2-871b-3a7930e27283%7D/ec-approves-expanded-use-of-stelara-for-moderately-to-severely-active-ulcerative-colitis|url-status=live}}</ref><ref>{{cite news|title=Ustekinumab (Stelara) PBS listed for severe Crohn's disease|url=https://www.nps.org.au/radar/articles/ustekinumab-stelara-pbs-listed-for-severe-crohns-disease|access-date=4 October 2019|newspaper=NPS Medicinewise|date=26 October 2017|archive-date=18 April 2019|archive-url=https://web.archive.org/web/20190418101429/https://www.nps.org.au/radar/articles/ustekinumab-stelara-pbs-listed-for-severe-crohns-disease|url-status=live}}</ref> It was found not effective for [[multiple sclerosis]].<ref name="ustekMS">{{cite journal | vauthors = Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH | title = Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study | journal = The Lancet. Neurology | volume = 7 | issue = 9 | pages = 796–804 | date = September 2008 | pmid = 18703004 | doi = 10.1016/S1474-4422(08)70173-X | s2cid = 20290673 }}</ref>
Note: Because the drug is not yet released for public use, the official drug's prescribing information and disclosure (required by federal law) is not available.


==Medical uses==
Patients enrolled in clinical trials of CNTO 1275 are scheduled to receive the drug by subcutaneous injections at doses of either 45 or 90 mg. The dosage and frequency varies by study and application (type of disease targeted). Generally the initial dosing interval is once per week followed by a step-down to once per month or even once every three months.
Ustekinumab is used to treat [[psoriasis]].<ref name="Stelara FDA label">{{cite web | title=Stelara- ustekinumab injection, solution Stelara- ustekinumab solution | website=DailyMed | date=24 March 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b | access-date=6 April 2020 | archive-date=2 July 2019 | archive-url=https://web.archive.org/web/20190702163317/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b | url-status=live }}</ref> This includes [[psoriatic arthritis]] when it affects the skin.<ref name=AHFS2017>{{cite web|title=Ustekinumab|url=https://www.drugs.com/monograph/ustekinumab.html|publisher=The American Society of Health-System Pharmacists|access-date=8 January 2017|archive-date=2 February 2017|archive-url=https://web.archive.org/web/20170202064829/https://www.drugs.com/monograph/ustekinumab.html|url-status=live}}</ref><ref name="Stelara FDA label" /> It is indicated for the treatment of adult and adolescent patients (12 years and older) with moderate to severe [[plaque psoriasis]] (Ps) who are candidates for [[phototherapy]] or systemic therapy, and adults with active psoriatic arthritis (PsA) alone or in combination with [[methotrexate]].<ref name="Stelara FDA label" /><ref>{{cite journal | vauthors = Toussirot E | title = The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases | journal = Inflammation & Allergy - Drug Targets | volume = 11 | issue = 2 | pages = 159–168 | date = April 2012 | pmid = 22280236 | doi = 10.2174/187152812800392805 }}</ref> It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.<ref name="Stelara FDA label" />


In the European Union, ustekinumab is authorized for the treatment of moderate to severe plaque psoriasis in people above the age of six years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A);<ref name="Stelara EPAR" /> active psoriatic arthritis in adults;<ref name="Stelara EPAR" /> moderately to severely active Crohn's disease in adults;<ref name="Stelara EPAR" /> and moderately to severely active ulcerative colitis in adults.<ref name="Stelara EPAR">{{cite web | title=Stelara EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stelara | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406181137/https://www.ema.europa.eu/en/medicines/human/EPAR/stelara | url-status=live }}</ref>


==Mode of action==
==Adverse effects==
The most common side effects include [[upper respiratory tract infection]], [[headache]], [[fatigue]], [[nausea]], [[vomiting]], nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, [[urinary tract infection]], sinusitis, abdominal pain, fever, and diarrhea.<ref name="Stelara FDA label" /> Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.<ref name="ustekinu">{{cite journal | vauthors = Weber J, Keam SJ | title = Ustekinumab | journal = BioDrugs | volume = 23 | issue = 1 | pages = 53–61 | year = 2009 | pmid = 19344192 | doi = 10.2165/00063030-200923010-00006 | s2cid = 265771199 }}</ref>


=== Pregnancy ===
Similar to the immunosuppressive function of [[Etanercept]](''Enbrel''), CNTO 1275 is designed to interfere with the triggering of the body's [[Inflammation|inflamatory response]] through the suppression of certain [[cytokines]]. Specifically, CNTO 1275 blocks [[interleukin]] [[IL-12]] and [[IL-23]] which help activiate certain [[T cell|T-cells]].
It is unknown if the medication is safe during pregnancy or breastfeeding.<ref name="Stelara SmPC" />


==External links==
==Mechanism of action==
Ustekinumab is designed to interfere with the triggering of the body's [[Inflammation|inflammatory response]] through the suppression of certain [[cytokines]]. Specifically, it blocks [[interleukin]] [[Interleukin 12|IL-12]] and [[Interleukin 23|IL-23]] which help activate certain [[T cell|T-cells]]. It binds to the [[Interleukin-12 subunit beta|p-40]] subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors.<ref>{{cite journal | vauthors = Koutruba N, Emer J, Lebwohl M | title = Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis | journal = Therapeutics and Clinical Risk Management | volume = 6 | pages = 123–141 | date = April 2010 | pmid = 20421912 | pmc = 2857612 | doi = 10.2147/tcrm.s5599 | doi-access = free }}</ref>
* [http://www.centocor.com/ Centocor official site]


==History==
* CNTO 1275 research studies registered with [[National Institutes of Health|U.S. National Institutes of Health]]:
In December 2007, a [[biologic license application]] with the US [[Food and Drug Administration]] (FDA) was filed by Centocor;<ref name="Stelara approval package" /><ref>{{cite press release | title=FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application | via=Drugs.com | publisher=Centocor | date=25 September 2009 | url=https://www.drugs.com/nda/ustekinumab_081219.html | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183734/https://www.drugs.com/nda/ustekinumab_081219.html | url-status=live }}</ref> and [[Janssen-Cilag]] International (collaborator) submitted a marketing authorization application to the [[European Medicines Agency]] (EMA). In November 2008, the [[Committee for Medicinal Products for Human Use]] of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies.<ref name="Stelara EPAR" />
** [http://www.clinicaltrials.gov/ct/show/NCT00207727 Phase II Study on Multiple Sclerosis (NCT00207727)]
** [http://www.clinicaltrials.gov/ct/show/NCT00320216 Phase II Study on Psoriasis (NCT00320216)]
** [http://www.clinicaltrials.gov/ct/show/NCT00267969 Phase III Study on Psoriasis (NCT00267969)]
** [http://www.clinicaltrials.gov/ct/show/NCT00307437 Phase III Study on Psoriasis (NCT00307437)]
** [http://www.clinicaltrials.gov/ct/show/NCT00267956 Phase II Study on Psoriatic Arthritis (NCT00267956)]


== Society and culture ==
* {{cite news |last=Sylvester |first=Bruce |url=http://www.docguide.com/news/content.nsf/news/852571020057CCF685257129005140C5 |title=CNTO 1275 Shows Efficacy for Psoriasis: Presented at AAD |publisher=Doctor's Guide Publishing |date=2006-03-06 |accessdate=2007-01-25}}
=== Legal status ===
Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe [[plaque psoriasis]].<ref>{{Cite web |url=http://news.idsk.com/viewer/story.php?CLIENT=INFOMAILER&NEWSID=prn121520081223240607 |title=Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis |access-date=16 December 2008 |archive-date=1 August 2013 |archive-url=https://web.archive.org/web/20130801043325/http://news.idsk.com/viewer/story.php?CLIENT=INFOMAILER&NEWSID=prn121520081223240607 |url-status=live }}</ref> In September 2013, the US [[Food and Drug Administration]] (FDA) approved the use of ustekinumab for the treatment of [[psoriatic arthritis]].<ref>{{cite web | title=New Drug Therapy Approvals 2022 | website=U.S. [[Food and Drug Administration]] (FDA) | date=31 December 2022 | url=https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022 | access-date=5 August 2024}}</ref>


In December 2008, [[Health Canada]] approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.<ref>{{cite web | title=Summary Basis of Decision for Stelara | website=[[Health Canada]] | date=27 May 2009 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00140 | access-date=28 August 2024}}</ref><ref>{{cite web | title=Stelara Product information | website=[[Health Canada]] | date=5 January 2009 | url=https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80608 | access-date=5 August 2024 | archive-date=5 August 2024 | archive-url=https://web.archive.org/web/20240805051647/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80608 | url-status=live }}</ref>

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.<ref>{{Cite web |url=http://www.empr.com/stelara-approved-for-moderate-to-severe-psoriasis/article/149760/ |title=Stelara approved for moderate to severe psoriasis. Sept 2009 |date=26 September 2009 |access-date=6 July 2010 |archive-date=20 September 2015 |archive-url=https://web.archive.org/web/20150920021419/http://www.empr.com/stelara-approved-for-moderate-to-severe-psoriasis/article/149760/ |url-status=live }}</ref><ref name="Stelara approval package">{{cite web | title=Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183104/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm | url-status=live }}</ref>

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease.<ref>{{cite web | title=Stelara (ustekinumab) Injection NDA #761044 | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 January 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183450/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm | url-status=live }}</ref>

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.<ref>{{Cite web |url=https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R |title=12 Sept 2017 |access-date=4 October 2019 |archive-date=15 March 2021 |archive-url=https://web.archive.org/web/20210315000734/https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R |url-status=live }}</ref>

In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.<ref name="healio.com"/><ref name="Stelara EPAR" />

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.<ref>{{cite web |title=Janssen's Stelara Gets FDA Approval for Ulcerative Colitis |url=https://www.fdanews.com/articles/193283-janssens-stelara-gets-fda-approval-for-ulcerative-colitis |website=FDA News |access-date=31 October 2019 |archive-date=13 January 2020 |archive-url=https://web.archive.org/web/20200113205721/https://www.fdanews.com/articles/193283-janssens-stelara-gets-fda-approval-for-ulcerative-colitis |url-status=live }}</ref><ref>{{cite web | title=Stelara: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761044 | access-date=6 April 2020 | archive-date=20 October 2020 | archive-url=https://web.archive.org/web/20201020044734/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761044 | url-status=live }}</ref>

==== Biosimilars ====
{{see also|Biosimilars}}

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.<ref name="FDA Wezlana press release">{{cite press release | title=FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases | website=U.S. Food and Drug Administration | date=31 October 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | access-date=13 November 2023 | archive-date=13 November 2023 | archive-url=https://web.archive.org/web/20231113104806/https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | url-status=live }} {{PD-notice}}</ref><ref name="FDA Biosimilar">{{cite web | title=Biosimilar Drug Information | website=U.S. [[Food and Drug Administration]] (FDA) | date=1 October 2024 | url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | access-date=2 December 2024}}</ref>

In November 2023, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uzpruvo, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis,<ref name="Uzpruvo: Pending EC decision" /> psoriatic arthritis and Crohn's disease in adults.<ref name="Uzpruvo: Pending EC decision" /> The applicant for this medicinal product is STADA Arzneimittel AG.<ref name="Uzpruvo: Pending EC decision" /> Uzpruvo is a biosimilar medicinal product.<ref name="Uzpruvo: Pending EC decision">{{cite web | title=Uzpruvo: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=10 November 2023 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/uzpruvo | access-date=13 November 2023 | archive-date=10 November 2023 | archive-url=https://web.archive.org/web/20231110192548/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/uzpruvo | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Uzpruvo was authorized for medical use in the European Union in January 2024.<ref name="Uzpruvo EPAR">{{cite web | title=Uzpruvo EPAR | website=European Medicines Agency | date=9 November 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo | access-date=14 January 2024 | archive-date=9 January 2024 | archive-url=https://web.archive.org/web/20240109150917/https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo | url-status=live }}</ref><ref name="Uzpruvo Product information">{{cite web | title=Uzpruvo Product information | website=Union Register of medicinal products | date=8 January 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1784.htm | access-date=14 January 2024 | archive-date=10 January 2024 | archive-url=https://web.archive.org/web/20240110084759/https://ec.europa.eu/health/documents/community-register/html/h1784.htm | url-status=live }}</ref>

In November 2023, Jamteki was approved for medical use in Canada.<ref name="Jamteki CA SBD">{{cite web | title=Summary Basis of Decision for Jamteki | website=[[Health Canada]] | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089 | access-date=23 July 2024 | archive-date=23 July 2024 | archive-url=https://web.archive.org/web/20240723044300/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089 | url-status=live }}</ref><ref>{{cite web | title=Regulatory Decision Summary for Jamteki | website=[[Health Canada]] | date=9 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702060641808 | access-date=28 August 2024}}</ref>

In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada.<ref>{{cite web | title=Summary Basis of Decision for Wezlana/Wezlana I.V. | website=[[Health Canada]] | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511 | access-date=28 August 2024}}</ref><ref>{{cite web | title=Regulatory Decision Summary for Wezlana/Wezlana I.V. | website=[[Health Canada]] | date=27 December 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125 | access-date=2 April 2024 | archive-date=2 April 2024 | archive-url=https://web.archive.org/web/20240402043205/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125 | url-status=live }}</ref>

In February 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.<ref name="Pyzchiva EPAR" /> The applicant for this medicinal product is Samsung Bioepis NL B.V.<ref name="Pyzchiva EPAR">{{cite web | title=Pyzchiva EPAR | website=European Medicines Agency | date=22 February 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | access-date=23 February 2024 | archive-date=23 February 2024 | archive-url=https://web.archive.org/web/20240223132607/https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Pyzchiva is a biosimilar medicinal product.<ref name="Pyzchiva EPAR" /> Pyzchiva was authorized for medical use in the European Union in April 2024.<ref name="Pyzchiva EPAR" /><ref name="Pyzchiva PI">{{cite web | title=Pyzchiva PI | website=Union Register of medicinal products | date=24 April 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1801.htm | access-date=30 September 2024}}</ref>

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.<ref name="Selarsdi PR" /><ref name="FDA Biosimilar" />

In April 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis and Crohn's disease in adults.<ref name="Wezenla EPAR" /><ref>{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 | website=European Medicines Agency | date=26 April 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | access-date=13 June 2024 | archive-date=5 July 2024 | archive-url=https://web.archive.org/web/20240705192841/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | url-status=live }}</ref> The applicant for this medicinal product is Amgen Technology (Ireland) UC.<ref name="Wezenla EPAR">{{cite web | title=Wezenla EPAR | website=[[European Medicines Agency]] | date=25 April 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | access-date=27 April 2024 | archive-date=6 August 2024 | archive-url=https://web.archive.org/web/20240806000155/https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Wezenla was authorized for medical use in the European Union in June 2024.<ref name="Wezenla EPAR" /><ref name="Wezenla PI">{{cite web | title=Wezenla PI | website=Union Register of medicinal products | date=22 June 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1823.htm | access-date=26 June 2024 | archive-date=26 June 2024 | archive-url=https://web.archive.org/web/20240626062648/https://ec.europa.eu/health/documents/community-register/html/h1823.htm | url-status=live }}</ref>

Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024.<ref name="Pyzchiva FDA label">{{Cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s000,761425s000lbl.pdf |title=Archived copy |access-date=2 July 2024 |archive-date=2 July 2024 |archive-url=https://web.archive.org/web/20240702044715/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s000,761425s000lbl.pdf |url-status=live }}</ref><ref name="FDA Biosimilar" />

In June 2024, the CHMP recommended granting a marketing authorization for Steqeyma, a biosimilar medicine for the treatment of adults with moderately-to severely-active Crohn's disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis.<ref name="Steqeyma EPAR" /><ref>{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 | website=European Medicines Agency | date=28 June 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | access-date=12 July 2024 | archive-date=12 July 2024 | archive-url=https://web.archive.org/web/20240712152232/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | url-status=live }}</ref> The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.<ref name="Steqeyma EPAR">{{cite web | title=Steqeyma EPAR | website=European Medicines Agency | date=27 June 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | access-date=12 July 2024 | archive-date=30 June 2024 | archive-url=https://web.archive.org/web/20240630134223/https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Steqeyma was authorized for medical use in the European Union in August 2024.<ref name="Steqeyma EPAR" /><ref name="Steqeyma PI">{{cite web | title=Steqeyma Product information | website=Union Register of medicinal products | date=23 August 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1844.htm | access-date=27 August 2024}}</ref>

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eksunbi, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.<ref name="Eksunbi EPAR" /> The applicant for this medicinal product is Samsung Bioepis NL B.V.<ref name="Eksunbi EPAR" /> Eksunbi is a biosimilar medicinal product.<ref name="Eksunbi EPAR">{{cite web | title=Eksunbi EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Eksunbi | access-date=29 July 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Eksunbi is a biosimilar medicinal product.<ref name="Eksunbi EPAR" /> Eksunbi was authorized for medical use in the European Union in September 2024.<ref name="Eksunbi EPAR" /><ref name="Eksunbi PI">{{cite web | title=Eksunbi Product information | website=Union Register of medicinal products | date=13 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1858.htm | access-date=17 September 2024}}</ref>

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.<ref name="Otulfi EPAR" /> The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.<ref name="Otulfi EPAR" /> Otulfi is a biosimilar medicinal product.<ref name="Otulfi EPAR">{{cite web | title=Otulfi EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi | access-date=27 July 2024 | archive-date=28 July 2024 | archive-url=https://web.archive.org/web/20240728125816/https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Otulfi was authorized for medical use in the European Union in September 2024.<ref name="Otulfi EPAR" /><ref name="Otulfi PI">{{cite web | title=Otulfi PI | website=Union Register of medicinal products | date=26 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1863.htm | access-date=30 September 2024}}</ref>

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn's disease.<ref name="Fymskina EPAR" /> The applicant for this medicinal product is Formycon AG.<ref name="Fymskina EPAR" /> Fymskina is a biosimilar medicinal product.<ref name="Fymskina EPAR">{{cite web | title=Fymskina EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina | access-date=27 July 2024 | archive-date=28 July 2024 | archive-url=https://web.archive.org/web/20240728062424/https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Fymskina was authorized for medical use in the European Union in September 2024.<ref name="Fymskina EPAR" /><ref name="Fymskina PI">{{cite web | title=Fymskina PI | website=Union Register of medicinal products | date=26 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1862.htm | access-date=30 September 2024}}</ref>

In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada.<ref>{{cite web | title=Regulatory Decision Summary for Steqeyma/Steqeyma IV | website=[[Health Canada]] | date=30 July 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095 | access-date=28 August 2024}}</ref>

In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada.<ref>{{cite web | title=Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab) | website=[[Health Canada]] | date=7 August 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772 | access-date=28 August 2024}}</ref><ref>{{cite web | title=Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab) | website=[[Health Canada]] | date=7 August 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977 | access-date=28 August 2024}}</ref>

In September 2024, ustekinumab-aauz (Otulfi) was approved for medical use in the United States.<ref name="Otulfi FDA label">https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf</ref><ref name="Otulfi FDA letter">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf</ref><ref name="FDA Biosimilar" />

Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024.<ref name="Imuldosa PR 20241014">{{cite press release | title=FDA Approves Imuldosa (ustekinumab-srlf), Accord BioPharma's Biosimilar to Stelara (ustekinumab), for the Treatment of Chronic Inflammatory Conditions | publisher=Accord BioPharma | via=PR Newswire | date=14 October 2024 | url=https://www.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html | access-date=14 October 2024}}</ref><ref>{{cite press release | title=US FDA Approves Dong-A ST's Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara | publisher=Dong-A ST | via=Business Wire | date=11 October 2024 | url=https://www.businesswire.com/news/home/20241011360476/en/US-FDA-Approves-Dong-A-ST%E2%80%99s-IMULDOSA%E2%84%A2-ustekinumab-srlf-a-Biosimilar-to-STELARA%C2%AE | access-date=14 October 2024}}</ref><ref name="FDA Biosimilar" />

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Absimky, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease or ulcerative colitis.<ref name="Absimky EPAR" /> The applicant for this medicinal product is Accord Healthcare S.L.U.<ref name="Absimky EPAR">{{cite web | title=Absimky EPAR | website=European Medicines Agency (EMA) | date=17 October 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/absimky | access-date=19 October 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Absimky is a biosimilar medicinal product.<ref name="Absimky EPAR" /><ref>{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024 | website=[[European Medicines Agency]] (EMA) | date=18 October 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024 | access-date=21 October 2024}}</ref>

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imuldosa, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.<ref name="Imuldosa EPAR" /> The applicant for this medicinal product is Accord Healthcare S.L.U.<ref name="Imuldosa EPAR" /> Imuldosa is a biosimilar medicinal product.<ref name="Imuldosa EPAR">{{cite web | title=Imuldosa EPAR | website=European Medicines Agency (EMA) | date=17 October 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/imuldosa | access-date=19 October 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Imuldosa was authorized for medical use in the European Union in December 2024.<ref>{{cite web | title=Imuldosa Product information | website=Union Register of medicinal products | date=16 December 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1872.htm | access-date=17 December 2024}}</ref>

Ustekinumab-kfce (Yesintek) was approved for medical use in the United States in December 2024.<ref name="Yesintek PR">{{cite web | title=U.S. FDA Approves Biocon Biologics' Yesintek, Bmab 1200 Biosimilar to J&J's Stelara (Ustekinumab) | publisher=Biocon Biologics | via=PR Newswire | date=2 December 2024 | url=https://www.prnewswire.com/news-releases/us-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab-302319272.html | access-date=2 December 2024}}</ref><ref name="FDA Biosimilar" />

In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yesintek, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.<ref name="Yesintek EPAR" /> The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.<ref name="Yesintek EPAR" /> Yesintek is a biosimilar medicinal product.<ref name="Yesintek EPAR" /> It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009.<ref name="Yesintek EPAR">{{cite web | title=Yesintek EPAR | website=European Medicines Agency (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/yesintek | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

Ustekinumab-stba (Steqeyma) was approved for medical use in the United States in December 2024.<ref name="Steqeyma FDA label">https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761338s000lbl.pdf</ref>

== References ==
{{reflist}}


{{Immunosuppressants}}
{{Immunosuppressants}}
{{Monoclonals for immune system}}
{{Interleukin receptor modulators}}
{{Portal bar | Medicine}}
{{Authority control}}


[[Category:Immunosuppressive agents]]
[[Category:Immunosuppressants]]
[[Category:Drugs developed by Johnson & Johnson]]
[[Category:Janssen Biotech]]
[[Category:Monoclonal antibodies]]
[[Category:Monoclonal antibodies]]
[[Category:Centocor]]
[[Category:Disease-modifying antirheumatic drugs]]

Latest revision as of 03:39, 18 December 2024

Ustekinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-12 and IL-23
Clinical data
Trade namesStelara
Other namesCNTO 1275
Biosimilarsustekinumab-aauz,[1] ustekinumab-aekn,[2] ustekinumab-auub,[3] ustekinumab-kfce,[4] ustekinumab-srlf,[5] ustekinumab-stba,[6] ustekinumab-ttwe,[7] Eksunbi,[8][9] Fymskina,[10][11] Imuldosa,[5] Jamteki,[12] Otulfi,[1][13][14] Pyzchiva,[7][15][16] Selarsdi,[2] Steqeyma,[17][18] Uzpruvo,[19] Wezlana,[3][20] Wezenla,[21][22] Yesintek[4]
AHFS/Drugs.comMonograph
MedlinePlusa611013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
Drug classImmunosuppressant interleukin inhibitor
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismunknown[26]
Elimination half-life15–32 days (average 3 weeks)[26]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6482H10004N1712O2016S46
Molar mass145648.06 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[29] targeting both IL-12 and IL-23.[30] It is administered either by intravenous infusion or subcutaneous injection.[29] The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.[31] Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells.[32] By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease.[32] Ustekinumab was developed by Centocor Ortho Biotech.[33]

Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union; and ulcerative colitis in the United States, and in the European Union to people who have not responded to more traditional treatments.[27][28][34][35] It was found not effective for multiple sclerosis.[36]

Medical uses

[edit]

Ustekinumab is used to treat psoriasis.[27] This includes psoriatic arthritis when it affects the skin.[29][27] It is indicated for the treatment of adult and adolescent patients (12 years and older) with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, and adults with active psoriatic arthritis (PsA) alone or in combination with methotrexate.[27][37] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.[27]

In the European Union, ustekinumab is authorized for the treatment of moderate to severe plaque psoriasis in people above the age of six years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A);[28] active psoriatic arthritis in adults;[28] moderately to severely active Crohn's disease in adults;[28] and moderately to severely active ulcerative colitis in adults.[28]

Adverse effects

[edit]

The most common side effects include upper respiratory tract infection, headache, fatigue, nausea, vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, fever, and diarrhea.[27] Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.[38]

Pregnancy

[edit]

It is unknown if the medication is safe during pregnancy or breastfeeding.[26]

Mechanism of action

[edit]

Ustekinumab is designed to interfere with the triggering of the body's inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL-12 and IL-23 which help activate certain T-cells. It binds to the p-40 subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors.[39]

History

[edit]

In December 2007, a biologic license application with the US Food and Drug Administration (FDA) was filed by Centocor;[33][40] and Janssen-Cilag International (collaborator) submitted a marketing authorization application to the European Medicines Agency (EMA). In November 2008, the Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies.[28]

Society and culture

[edit]
[edit]

Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.[41] In September 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.[42]

In December 2008, Health Canada approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.[43][44]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.[45][33]

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease.[46]

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.[47]

In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[34][28]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[48][49]

Biosimilars

[edit]
See also: Biosimilars

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.[3][50]

In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uzpruvo, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis,[51] psoriatic arthritis and Crohn's disease in adults.[51] The applicant for this medicinal product is STADA Arzneimittel AG.[51] Uzpruvo is a biosimilar medicinal product.[51] Uzpruvo was authorized for medical use in the European Union in January 2024.[19][52]

In November 2023, Jamteki was approved for medical use in Canada.[12][53]

In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada.[54][55]

In February 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.[15] The applicant for this medicinal product is Samsung Bioepis NL B.V.[15] Pyzchiva is a biosimilar medicinal product.[15] Pyzchiva was authorized for medical use in the European Union in April 2024.[15][16]

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.[2][50]

In April 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis and Crohn's disease in adults.[21][56] The applicant for this medicinal product is Amgen Technology (Ireland) UC.[21] Wezenla was authorized for medical use in the European Union in June 2024.[21][22]

Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024.[7][50]

In June 2024, the CHMP recommended granting a marketing authorization for Steqeyma, a biosimilar medicine for the treatment of adults with moderately-to severely-active Crohn's disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis.[17][57] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.[17] Steqeyma was authorized for medical use in the European Union in August 2024.[17][18]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eksunbi, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.[8] The applicant for this medicinal product is Samsung Bioepis NL B.V.[8] Eksunbi is a biosimilar medicinal product.[8] Eksunbi is a biosimilar medicinal product.[8] Eksunbi was authorized for medical use in the European Union in September 2024.[8][9]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[13] The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.[13] Otulfi is a biosimilar medicinal product.[13] Otulfi was authorized for medical use in the European Union in September 2024.[13][14]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn's disease.[10] The applicant for this medicinal product is Formycon AG.[10] Fymskina is a biosimilar medicinal product.[10] Fymskina was authorized for medical use in the European Union in September 2024.[10][11]

In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada.[58]

In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada.[59][60]

In September 2024, ustekinumab-aauz (Otulfi) was approved for medical use in the United States.[1][61][50]

Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024.[5][62][50]

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Absimky, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease or ulcerative colitis.[63] The applicant for this medicinal product is Accord Healthcare S.L.U.[63] Absimky is a biosimilar medicinal product.[63][64]

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imuldosa, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[65] The applicant for this medicinal product is Accord Healthcare S.L.U.[65] Imuldosa is a biosimilar medicinal product.[65] Imuldosa was authorized for medical use in the European Union in December 2024.[66]

Ustekinumab-kfce (Yesintek) was approved for medical use in the United States in December 2024.[4][50]

In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yesintek, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[32] The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.[32] Yesintek is a biosimilar medicinal product.[32] It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009.[32]

Ustekinumab-stba (Steqeyma) was approved for medical use in the United States in December 2024.[6]

References

[edit]
  1. ^ a b c https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf
  2. ^ a b c "Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)" (Press release). Alvotech. 16 April 2024. Archived from the original on 17 April 2024. Retrieved 17 April 2024 – via GlobeNewswire.
  3. ^ a b c "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases". U.S. Food and Drug Administration (Press release). 31 October 2023. Archived from the original on 13 November 2023. Retrieved 13 November 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ a b c "U.S. FDA Approves Biocon Biologics' Yesintek, Bmab 1200 Biosimilar to J&J's Stelara (Ustekinumab)". Biocon Biologics. 2 December 2024. Retrieved 2 December 2024 – via PR Newswire.
  5. ^ a b c "FDA Approves Imuldosa (ustekinumab-srlf), Accord BioPharma's Biosimilar to Stelara (ustekinumab), for the Treatment of Chronic Inflammatory Conditions" (Press release). Accord BioPharma. 14 October 2024. Retrieved 14 October 2024 – via PR Newswire.
  6. ^ a b https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761338s000lbl.pdf
  7. ^ a b c "Archived copy" (PDF). Archived (PDF) from the original on 2 July 2024. Retrieved 2 July 2024.{{cite web}}: CS1 maint: archived copy as title (link)
  8. ^ a b c d e f "Eksunbi EPAR". European Medicines Agency. 25 July 2024. Retrieved 29 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ a b "Eksunbi Product information". Union Register of medicinal products. 13 September 2024. Retrieved 17 September 2024.
  10. ^ a b c d e "Fymskina EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ^ a b "Fymskina PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  12. ^ a b "Summary Basis of Decision for Jamteki". Health Canada. 1 September 2012. Archived from the original on 23 July 2024. Retrieved 23 July 2024.
  13. ^ a b c d e "Otulfi EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ^ a b "Otulfi PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  15. ^ a b c d e "Pyzchiva EPAR". European Medicines Agency. 22 February 2024. Archived from the original on 23 February 2024. Retrieved 23 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. ^ a b "Pyzchiva PI". Union Register of medicinal products. 24 April 2024. Retrieved 30 September 2024.
  17. ^ a b c d "Steqeyma EPAR". European Medicines Agency. 27 June 2024. Archived from the original on 30 June 2024. Retrieved 12 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  18. ^ a b "Steqeyma Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
  19. ^ a b "Uzpruvo EPAR". European Medicines Agency. 9 November 2023. Archived from the original on 9 January 2024. Retrieved 14 January 2024.
  20. ^ a b c "Wezlana APMDS". Therapeutic Goods Administration (TGA). 30 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
  21. ^ a b c d "Wezenla EPAR". European Medicines Agency. 25 April 2024. Archived from the original on 6 August 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  22. ^ a b "Wezenla PI". Union Register of medicinal products. 22 June 2024. Archived from the original on 26 June 2024. Retrieved 26 June 2024.
  23. ^ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. 26 November 2019. Archived from the original on 22 May 2020. Retrieved 6 April 2020.
  24. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 31 March 2024. Retrieved 31 March 2024.
  25. ^ "Regulatory Decision Summary for Stelara". Health Canada. 16 June 2020. Retrieved 28 August 2024.
  26. ^ a b c d "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). 27 February 2020. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  27. ^ a b c d e f g "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". DailyMed. 24 March 2020. Archived from the original on 2 July 2019. Retrieved 6 April 2020.
  28. ^ a b c d e f g h "Stelara EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  29. ^ a b c "Ustekinumab". The American Society of Health-System Pharmacists. Archived from the original on 2 February 2017. Retrieved 8 January 2017.
  30. ^ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC 2726595. PMID 20069753.
  31. ^ Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U (May 2007). "Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275". Cellular Immunology. 247 (1): 1–11. doi:10.1016/j.cellimm.2007.06.006. PMID 17761156.
  32. ^ a b c d e f "Yesintek EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 16 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  33. ^ a b c "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  34. ^ a b "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. Archived from the original on 9 September 2019. Retrieved 26 September 2019.
  35. ^ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. 26 October 2017. Archived from the original on 18 April 2019. Retrieved 4 October 2019.
  36. ^ Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH (September 2008). "Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study". The Lancet. Neurology. 7 (9): 796–804. doi:10.1016/S1474-4422(08)70173-X. PMID 18703004. S2CID 20290673.
  37. ^ Toussirot E (April 2012). "The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases". Inflammation & Allergy - Drug Targets. 11 (2): 159–168. doi:10.2174/187152812800392805. PMID 22280236.
  38. ^ Weber J, Keam SJ (2009). "Ustekinumab". BioDrugs. 23 (1): 53–61. doi:10.2165/00063030-200923010-00006. PMID 19344192. S2CID 265771199.
  39. ^ Koutruba N, Emer J, Lebwohl M (April 2010). "Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis". Therapeutics and Clinical Risk Management. 6: 123–141. doi:10.2147/tcrm.s5599. PMC 2857612. PMID 20421912.
  40. ^ "FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application" (Press release). Centocor. 25 September 2009. Archived from the original on 6 April 2020. Retrieved 6 April 2020 – via Drugs.com.
  41. ^ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". Archived from the original on 1 August 2013. Retrieved 16 December 2008.
  42. ^ "New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 31 December 2022. Retrieved 5 August 2024.
  43. ^ "Summary Basis of Decision for Stelara". Health Canada. 27 May 2009. Retrieved 28 August 2024.
  44. ^ "Stelara Product information". Health Canada. 5 January 2009. Archived from the original on 5 August 2024. Retrieved 5 August 2024.
  45. ^ "Stelara approved for moderate to severe psoriasis. Sept 2009". 26 September 2009. Archived from the original on 20 September 2015. Retrieved 6 July 2010.
  46. ^ "Stelara (ustekinumab) Injection NDA #761044". U.S. Food and Drug Administration (FDA). 12 January 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  47. ^ "12 Sept 2017". Archived from the original on 15 March 2021. Retrieved 4 October 2019.
  48. ^ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". FDA News. Archived from the original on 13 January 2020. Retrieved 31 October 2019.
  49. ^ "Stelara: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 20 October 2020. Retrieved 6 April 2020.
  50. ^ a b c d e f "Biosimilar Drug Information". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 2 December 2024.
  51. ^ a b c d "Uzpruvo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 10 November 2023. Retrieved 13 November 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  52. ^ "Uzpruvo Product information". Union Register of medicinal products. 8 January 2024. Archived from the original on 10 January 2024. Retrieved 14 January 2024.
  53. ^ "Regulatory Decision Summary for Jamteki". Health Canada. 9 November 2023. Retrieved 28 August 2024.
  54. ^ "Summary Basis of Decision for Wezlana/Wezlana I.V." Health Canada. 1 September 2012. Retrieved 28 August 2024.
  55. ^ "Regulatory Decision Summary for Wezlana/Wezlana I.V." Health Canada. 27 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  56. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Archived from the original on 5 July 2024. Retrieved 13 June 2024.
  57. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  58. ^ "Regulatory Decision Summary for Steqeyma/Steqeyma IV". Health Canada. 30 July 2024. Retrieved 28 August 2024.
  59. ^ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada. 7 August 2024. Retrieved 28 August 2024.
  60. ^ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada. 7 August 2024. Retrieved 28 August 2024.
  61. ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf
  62. ^ "US FDA Approves Dong-A ST's Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara" (Press release). Dong-A ST. 11 October 2024. Retrieved 14 October 2024 – via Business Wire.
  63. ^ a b c "Absimky EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  64. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". European Medicines Agency (EMA). 18 October 2024. Retrieved 21 October 2024.
  65. ^ a b c "Imuldosa EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  66. ^ "Imuldosa Product information". Union Register of medicinal products. 16 December 2024. Retrieved 17 December 2024.
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