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


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=April 26, 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | access-date=June 13, 2024}}</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=April 25, 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | access-date=April 27, 2024 }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
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=April 26, 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | access-date=June 13, 2024}}</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=April 25, 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | access-date=April 27, 2024 }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Wezenla was approved for medical use in the European Union in June 2024.<ref>{{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}}</ref>


== References ==
== References ==

Revision as of 06:26, 26 June 2024

Ustekinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-12 and IL-23
Clinical data
Trade namesStelara
Other namesCNTO 1275
Biosimilarsustekinumab-aekn,[1] ustekinumab-auub,[2] Pyzchiva,[3] Selarsdi,[1] Uzpruvo,[4] Wezlana[2][5]
AHFS/Drugs.comMonograph
MedlinePlusa611013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismunknown[9]
Elimination half-life15–32 days (average 3 weeks)[9]
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 developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[13] targeting both IL-12 and IL-23.[14]

Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union, and ulcerative colitis in the US, and in the EU to people who have not responded to more traditional treatments.[10][11][15][16] It was found not effective for multiple sclerosis.[17]

It is administered either by intravenous infusion or subcutaneous injection.[13] 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.[18]

Medical uses

Ustekinumab is used to treat psoriasis.[10] This includes psoriatic arthritis when it affects the skin.[13][10] 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.[10][19] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.[10]

In the European Union, ustekinumab is approved to treat moderate to severe plaque psoriasis in adults and children 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);[11] active psoriatic arthritis in adults;[11] moderately to severely active Crohn's disease in adults;[11] and moderately to severely active ulcerative colitis in adults.[11]

Adverse effects

According to information provided by Centocor, maker of one medication based on ustekinumab, their version of ustekinumab is associated with several types of serious adverse effects. These include an increased risk of infection, such as by tuberculosis and an increased risk of certain types of cancer. As with some other immunosuppressant drugs like ciclosporin, the brain swelling of posterior reversible encephalopathy syndrome is a risk. The pharmaceutical company also reports serious allergic reaction as a possible side effect. More common side effects are upper respiratory infection, headache, and tiredness.[20]

Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.[21]

Pregnancy

It is unknown if the medication is safe during pregnancy or breastfeeding.[9]

Mechanism of action

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.[22]

History

As of January 2007, there were five NIH-listed research studies involving CNTO 1275 on a multinational basis, including three phase II and two phase III trials. Three studies were focused on patients with psoriasis, one on psoriatic arthritis, and one on multiple sclerosis.[citation needed]

On December 4, 2007, a Biologic License Application (BLA) with the US Food and Drug Administration (FDA) was filed by Centocor and Janssen-Cilag International (collaborator) submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). On November 21, 2008, the Committee for Medicinal Products for Human Use (CHMP) 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.[11][23]

Society and culture

Since 2009, ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.[24] On September 24, 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.[citation needed]

On December 12, 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.[25]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.[26][27]

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease.[28]

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.[29]

In 2019, the European Commission approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[15][11]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[30][31]

Biosimilars

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.[2]

In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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,[32] psoriatic arthritis and Crohn's disease in adults.[32] The applicant for this medicinal product is STADA Arzneimittel AG.[32] Uzpruvo is a biosimilar medicinal product.[32] Uzpruvo was approved for medical use in the European Union in January 2024.[4][12]

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.[3] The applicant for this medicinal product is Samsung Bioepis NL B.V.[3] Pyzchiva is a biosimilar medicinal product.[3] Pyzchiva was approved for medical use in the European Union in April 2024.[3]

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.[1]

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.[33][34] The applicant for this medicinal product is Amgen Technology (Ireland) UC.[33] Wezenla was approved for medical use in the European Union in June 2024.[35]

References

  1. ^ a b c "Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)" (Press release). Alvotech. April 16, 2024. Archived from the original on April 17, 2024. Retrieved April 17, 2024 – via GlobeNewswire.
  2. ^ a b c "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases". U.S. Food and Drug Administration (Press release). October 31, 2023. Archived from the original on November 13, 2023. Retrieved November 13, 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ a b c d e "Pyzchiva EPAR". European Medicines Agency. February 22, 2024. Archived from the original on February 23, 2024. Retrieved February 23, 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ^ a b c "Uzpruvo EPAR". European Medicines Agency. November 9, 2023. Archived from the original on January 9, 2024. Retrieved January 14, 2024.
  5. ^ a b c "Wezlana APMDS". Therapeutic Goods Administration (TGA). January 30, 2024. Archived from the original on February 8, 2024. Retrieved March 7, 2024.
  6. ^ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. November 26, 2019. Archived from the original on May 22, 2020. Retrieved April 6, 2020.
  7. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). June 21, 2022. Archived from the original on March 31, 2024. Retrieved March 31, 2024.
  8. ^ "Regulatory Decision Summary for Wezlana/Wezlana I.V." Drug and Health Products Portal. December 27, 2023. Archived from the original on April 2, 2024. Retrieved April 2, 2024.
  9. ^ a b c d "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). February 27, 2020. Archived from the original on April 6, 2020. Retrieved April 6, 2020.
  10. ^ a b c d e f "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". DailyMed. March 24, 2020. Archived from the original on July 2, 2019. Retrieved April 6, 2020.
  11. ^ a b c d e f g h "Stelara EPAR". European Medicines Agency (EMA). September 17, 2018. Archived from the original on April 6, 2020. Retrieved April 6, 2020.
  12. ^ a b "Uzpruvo Product information". Union Register of medicinal products. January 8, 2024. Archived from the original on January 10, 2024. Retrieved January 14, 2024.
  13. ^ a b c "Ustekinumab". The American Society of Health-System Pharmacists. Archived from the original on February 2, 2017. Retrieved January 8, 2017.
  14. ^ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC 2726595. PMID 20069753.
  15. ^ a b "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. Archived from the original on September 9, 2019. Retrieved September 26, 2019.
  16. ^ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. October 26, 2017. Archived from the original on April 18, 2019. Retrieved October 4, 2019.
  17. ^ 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.
  18. ^ 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.
  19. ^ 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.
  20. ^ "Important Safety Information". Stelara (ustekinumab). Janssen Biotech. May 22, 2019. Archived from the original on March 29, 2021. Retrieved December 31, 2010.
  21. ^ Weber J, Keam SJ (2009). "Ustekinumab". BioDrugs. 23 (1): 53–61. doi:10.2165/00063030-200923010-00006. PMID 19344192. S2CID 265771199.
  22. ^ 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.
  23. ^ "FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application". Drugs.com (Press release). Centocor. September 25, 2009. Archived from the original on April 6, 2020. Retrieved April 6, 2020.
  24. ^ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". Archived from the original on August 1, 2013. Retrieved December 16, 2008.
  25. ^ "drugbank.ca". Archived from the original on January 31, 2020. Retrieved October 4, 2019.
  26. ^ "Stelara approved for moderate to severe psoriasis. Sept 2009". September 26, 2009. Archived from the original on September 20, 2015. Retrieved July 6, 2010.
  27. ^ "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". U.S. Food and Drug Administration (FDA). December 24, 1999. Archived from the original on April 6, 2020. Retrieved April 6, 2020.
  28. ^ "Stelara (ustekinumab) Injection NDA #761044". U.S. Food and Drug Administration (FDA). January 12, 2018. Archived from the original on April 6, 2020. Retrieved April 6, 2020.
  29. ^ "12 Sept 2017". Archived from the original on March 15, 2021. Retrieved October 4, 2019.
  30. ^ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". FDA News. Archived from the original on January 13, 2020. Retrieved October 31, 2019.
  31. ^ "Stelara: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on October 20, 2020. Retrieved April 6, 2020.
  32. ^ a b c d "Uzpruvo: Pending EC decision". European Medicines Agency (EMA). November 10, 2023. Archived from the original on November 10, 2023. Retrieved November 13, 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  33. ^ a b "Wezenla EPAR". European Medicines Agency. April 25, 2024. Retrieved April 27, 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  34. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). April 26, 2024. Retrieved June 13, 2024.
  35. ^ "Wezenla PI". Union Register of medicinal products. June 22, 2024. Retrieved June 26, 2024.
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