Jump to content

Ritlecitinib: Difference between revisions

From Wikipedia, the free encyclopedia
Browse history interactively
← Previous edit
Content deleted Content added
VisualWikitext
no longer a stub
infobox
 
(6 intermediate revisions by 3 users not shown)
Line 15: Line 15:
| MedlinePlus = a624015
| MedlinePlus = a624015
| DailyMedID = Ritlecitinib
| DailyMedID = Ritlecitinib
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = D
| pregnancy_AU_comment =
| pregnancy_AU_comment = <ref name="Litfulo APMDS" />
| pregnancy_category =
| pregnancy_category =
| routes_of_administration = [[By mouth]]
| routes_of_administration = [[By mouth]]
Line 25: Line 25:


<!-- Legal status -->
<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU = S4
| legal_AU_comment = <ref>https://www.tga.gov.au/resources/prescription-medicines-registrations/litfulo-pfizer-australia-pty-ltd</ref><ref name="Litfulo APMDS">{{cite web | title=Litfulo (ritlecitinib) | website=Therapeutic Goods Administration (TGA) | date=30 July 2024 | url=https://www.tga.gov.au/resources/auspmd/litfulo-ritlecitinib | access-date=12 October 2024}}</ref>
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA = Rx-only
| legal_CA_comment = <ref>{{cite web | title=Litfulo Product information | website=[[Health Canada]] | date=13 February 2024 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/103199 | access-date=3 March 2024}}</ref><ref name="CA PDL additions" /><ref>{{cite web | title=Regulatory Decision Summary for Litfulo | website=Drug and Health Products Portal | date=29 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710791169293 | access-date=2 April 2024}}</ref>
| legal_CA_comment = <ref>{{cite web | title=Litfulo Product information | website=[[Health Canada]] | date=13 February 2024 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/103199 | access-date=3 March 2024}}</ref><ref name="Litfulo CA SBD">{{cite web | title=Summary Basis of Decision for Litfulo | website=[[Health Canada]] | date=18 July 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068 | access-date=28 August 2024}}</ref><ref>{{cite web | title=Regulatory Decision Summary for Litfulo | website=[[Health Canada]] | date=29 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710791169293 | access-date=2 April 2024}}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_DE_comment =
Line 96: Line 96:
}}
}}


'''Ritlecitinib''', sold under the brand name '''Litfulo''', is a medication used for the treatment of severe [[alopecia areata]] ([[hair loss]]).<ref name="Litfulo FDA label" /> Ritlecitinib is a [[kinase inhibitor]] which inhibits [[Janus kinase 3]] and [[tyrosine kinase]].<ref name="Litfulo FDA label" /><ref>{{cite web | title=Ritlecitinib | website=Inxight Drugs | url=https://drugs.ncats.io/drug/2OYE00PC25 | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=https://web.archive.org/web/20230625051310/https://drugs.ncats.io/drug/2OYE00PC25 | url-status=live }}</ref><ref>{{cite journal | vauthors = Ramírez-Marín HA, Tosti A | title = Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata | journal = Drug Design, Development and Therapy | volume = 16 | issue = | pages = 363–374 | date = February 2022 | pmid = 35210753 | pmc = 8860347 | doi = 10.2147/DDDT.S334727 | doi-access = free }}</ref>
'''Ritlecitinib''', sold under the brand name '''Litfulo''', is a [[medication]] used for the treatment of severe [[alopecia areata]] ([[hair loss]]).<ref name="Litfulo FDA label" /> Ritlecitinib is a [[kinase inhibitor]] which inhibits [[Janus kinase 3]] and [[tyrosine kinase]].<ref name="Litfulo FDA label" /><ref>{{cite web | title=Ritlecitinib | website=Inxight Drugs | url=https://drugs.ncats.io/drug/2OYE00PC25 | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=https://web.archive.org/web/20230625051310/https://drugs.ncats.io/drug/2OYE00PC25 | url-status=live }}</ref><ref>{{cite journal | vauthors = Ramírez-Marín HA, Tosti A | title = Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata | journal = Drug Design, Development and Therapy | volume = 16 | issue = | pages = 363–374 | date = February 2022 | pmid = 35210753 | pmc = 8860347 | doi = 10.2147/DDDT.S334727 | doi-access = free }}</ref>


The most common side effects include headache, diarrhea, acne, rashes, eczema, fever, mouth ulcers, dizziness, shingles rash, and abnormal findings in some laboratory test results.<ref name="FDA snapshot">{{cite web | title=Drug Trials Snapshots: Litfulo | website=U.S. Food and Drug Administration | date=23 June 2023 | url=https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo | access-date=29 April 2024}} {{PD-notice}}</ref>
The most common side effects include headache, diarrhea, acne, rashes, eczema, fever, mouth ulcers, dizziness, shingles rash, and abnormal findings in some laboratory test results.<ref name="FDA snapshot">{{cite web | title=Drug Trials Snapshots: Litfulo | website=U.S. Food and Drug Administration | date=23 June 2023 | url=https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo | access-date=29 April 2024}} {{PD-notice}}</ref>


Ritlecitinib was approved for medical use in the United States in June 2023,<ref name="Litfulo FDA label" /><ref name="FDA snapshot" /><ref>{{cite press release | title=FDA Approves Pfizer's Litfulo (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | publisher=Pfizer | via=Business Wire | date=23 June 2023 | url=https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=https://web.archive.org/web/20230625051309/https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata | url-status=live }}</ref> in the European Union in September 2023,<ref name="Litfulo EPAR" /> and in Canada in February 2024.<ref name="CA PDL additions">{{cite web | title=Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28] | website=[[Health Canada]] | date=28 February 2024 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2024-02-28.html | access-date=2 March 2024}}</ref>
Ritlecitinib was approved for medical use in the United States in June 2023,<ref name="Litfulo FDA label" /><ref name="FDA snapshot" /><ref>{{cite press release | title=FDA Approves Pfizer's Litfulo (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | publisher=Pfizer | via=Business Wire | date=23 June 2023 | url=https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=https://web.archive.org/web/20230625051309/https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata | url-status=live }}</ref> in the European Union in September 2023,<ref name="Litfulo EPAR" /> and in Canada in November 2023.<ref name="Litfulo CA SBD" />


== Medical uses ==
== Medical uses ==
Line 106: Line 106:


== History ==
== History ==
The FDA approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata.<ref name="FDA snapshot" /> The efficacy and safety of ritlecitinib were evaluated in a randomized, double-blind, placebo controlled trial in 718 participants twelve years of age and older with alopecia areata with ≥50% scalp hair loss, including alopecia totalis and alopecia universalis.<ref name="FDA snapshot" /> The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens.<ref name="FDA snapshot" /> The safety evaluation was also supported by two placebo-controlled trials in which 80 participants were randomized to ritlecitinib 200 mg once daily for four weeks followed by 50 mg once daily and 82 participants were randomized to placebo.<ref name="FDA snapshot" /> The trial was conducted at 128 sites in 18 countries in Argentina, Australia, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, Japan, Republic of Korea, Mexico, Poland, Russian Federation, Spain, Taiwan, the United Kingdom, and the United States.<ref name="FDA snapshot" />
The US Food and Drug Administration (FDA) approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata.<ref name="FDA snapshot" /> The efficacy and safety of ritlecitinib were evaluated in a randomized, double-blind, placebo controlled trial in 718 participants twelve years of age and older with alopecia areata with ≥50% scalp hair loss, including alopecia totalis and alopecia universalis.<ref name="FDA snapshot" /> The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens.<ref name="FDA snapshot" /> The safety evaluation was also supported by two placebo-controlled trials in which 80 participants were randomized to ritlecitinib 200 mg once daily for four weeks followed by 50 mg once daily and 82 participants were randomized to placebo.<ref name="FDA snapshot" /> The trial was conducted at 128 sites in 18 countries in Argentina, Australia, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, Japan, Republic of Korea, Mexico, Poland, Russian Federation, Spain, Taiwan, the United Kingdom, and the United States.<ref name="FDA snapshot" />


== Society and culture ==
== Society and culture ==
=== Legal status ===
In 2023, ritlecitinib was approved for medical use in the United States,<ref name="Litfulo FDA label" /><ref name="FDA snapshot" /> in the European Union,<ref name="Litfulo EPAR" /> and in Canada.<ref name="Litfulo CA SBD" />

=== Economics ===
=== Economics ===
The annual list price of a prescription is {{US$|49,000}}.<ref>{{Cite web | vauthors = Kansteiner F | date = 26 June 2023 |url=https://www.fiercepharma.com/pharma/pfizers-litfulo-enters-scene-alopecia-adolescent-nod-rival-lillys-olumiant |title=Pfizer's Litfulo enters the scene in alopecia with adolescent nod to rival Lilly's Olumiant | work = Fierce Pharma |access-date=18 September 2023 |archive-date=8 July 2023 |archive-url=https://web.archive.org/web/20230708164950/https://www.fiercepharma.com/pharma/pfizers-litfulo-enters-scene-alopecia-adolescent-nod-rival-lillys-olumiant |url-status=live }}</ref>
The annual list price of ritlecitinib is {{US$|49,000}}.<ref>{{Cite web | vauthors = Kansteiner F | date = 26 June 2023 |url=https://www.fiercepharma.com/pharma/pfizers-litfulo-enters-scene-alopecia-adolescent-nod-rival-lillys-olumiant |title=Pfizer's Litfulo enters the scene in alopecia with adolescent nod to rival Lilly's Olumiant | work = Fierce Pharma |access-date=18 September 2023 |archive-date=8 July 2023 |archive-url=https://web.archive.org/web/20230708164950/https://www.fiercepharma.com/pharma/pfizers-litfulo-enters-scene-alopecia-adolescent-nod-rival-lillys-olumiant |url-status=live }}</ref>


== References ==
== References ==
Line 118: Line 121:
{{refbegin}}
{{refbegin}}
* {{cite journal | vauthors = Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E | title = Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers | journal = The Journal of Allergy and Clinical Immunology | volume = 149 | issue = 4 | pages = 1318–1328 | date = April 2022 | pmid = 34863853 | doi = 10.1016/j.jaci.2021.10.036 | s2cid = 244824663 | doi-access = free }}
* {{cite journal | vauthors = Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E | title = Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers | journal = The Journal of Allergy and Clinical Immunology | volume = 149 | issue = 4 | pages = 1318–1328 | date = April 2022 | pmid = 34863853 | doi = 10.1016/j.jaci.2021.10.036 | s2cid = 244824663 | doi-access = free }}
* {{cite journal | vauthors = King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R | title = Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial | journal = Lancet | location = London, England | volume = 401 | issue = 10387 | pages = 1518–1529 | date = May 2023 | pmid = 37062298 | doi = 10.1016/S0140-6736(23)00222-2 | s2cid = 258114404 }}
* {{cite journal | vauthors = King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R | title = Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial | journal = Lancet | location = London, England | volume = 401 | issue = 10387 | pages = 1518–1529 | date = May 2023 | pmid = 37062298 | doi = 10.1016/S0140-6736(23)00222-2 | s2cid = 258114404 | url = https://escholarship.org/uc/item/4qw041s6 }}
{{refend}}
{{refend}}


Line 124: Line 127:
* {{ClinicalTrialsGov|NCT03732807|PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)}}
* {{ClinicalTrialsGov|NCT03732807|PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)}}


{{Immunosuppressants}}
{{Cytokine receptor modulators}}
{{Cytokine receptor modulators}}
{{Other dermatological preparations}}
{{Other dermatological preparations}}

Latest revision as of 02:49, 12 October 2024

Ritlecitinib
Clinical data
Trade namesLitfulo
Other namesPF-06651600
AHFS/Drugs.comMonograph
MedlinePlusa624015
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
Chemical and physical data
FormulaC15H19N5O
Molar mass285.351 g·mol−1
3D model (JSmol)
  • C[C@H]1CC[C@H](CN1C(=O)C=C)NC2=C3C=CNC3=NC=N2
  • InChI=1S/C15H19N5O/c1-3-13(21)20-8-11(5-4-10(20)2)19-15-12-6-7-16-14(12)17-9-18-15/h3,6-7,9-11H,1,4-5,8H2,2H3,(H2,16,17,18,19)/t10-,11+/m0/s1
  • Key:CBRJPFGIXUFMTM-WDEREUQCSA-N
  • Key:YOZLVAFWYLSRRN-VZXYPILPSA-N

Ritlecitinib, sold under the brand name Litfulo, is a medication used for the treatment of severe alopecia areata (hair loss).[6] Ritlecitinib is a kinase inhibitor which inhibits Janus kinase 3 and tyrosine kinase.[6][9][10]

The most common side effects include headache, diarrhea, acne, rashes, eczema, fever, mouth ulcers, dizziness, shingles rash, and abnormal findings in some laboratory test results.[11]

Ritlecitinib was approved for medical use in the United States in June 2023,[6][11][12] in the European Union in September 2023,[7] and in Canada in November 2023.[4]

Medical uses

[edit]

Ritlecitinib is indicated for the treatment of severe alopecia areata for individuals twelve years of age and older.[6][7]

History

[edit]

The US Food and Drug Administration (FDA) approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata.[11] The efficacy and safety of ritlecitinib were evaluated in a randomized, double-blind, placebo controlled trial in 718 participants twelve years of age and older with alopecia areata with ≥50% scalp hair loss, including alopecia totalis and alopecia universalis.[11] The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens.[11] The safety evaluation was also supported by two placebo-controlled trials in which 80 participants were randomized to ritlecitinib 200 mg once daily for four weeks followed by 50 mg once daily and 82 participants were randomized to placebo.[11] The trial was conducted at 128 sites in 18 countries in Argentina, Australia, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, Japan, Republic of Korea, Mexico, Poland, Russian Federation, Spain, Taiwan, the United Kingdom, and the United States.[11]

Society and culture

[edit]
[edit]

In 2023, ritlecitinib was approved for medical use in the United States,[6][11] in the European Union,[7] and in Canada.[4]

Economics

[edit]

The annual list price of ritlecitinib is US$49,000.[13]

References

[edit]
  1. ^ a b "Litfulo (ritlecitinib)". Therapeutic Goods Administration (TGA). 30 July 2024. Retrieved 12 October 2024.
  2. ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/litfulo-pfizer-australia-pty-ltd
  3. ^ "Litfulo Product information". Health Canada. 13 February 2024. Retrieved 3 March 2024.
  4. ^ a b c "Summary Basis of Decision for Litfulo". Health Canada. 18 July 2024. Retrieved 28 August 2024.
  5. ^ "Regulatory Decision Summary for Litfulo". Health Canada. 29 November 2023. Retrieved 2 April 2024.
  6. ^ a b c d e f "Litfulo- ritlecitinib capsule". DailyMed. U.S. National Library of Medicine. 23 June 2023. Archived from the original on 29 August 2023. Retrieved 28 August 2023.
  7. ^ a b c d "Litfulo EPAR". European Medicines Agency. 18 September 2023. Archived from the original on 19 September 2023. Retrieved 20 September 2023.
  8. ^ "Litfulo Product information". Union Register of medicinal products. 18 September 2023. Archived from the original on 1 October 2023. Retrieved 1 October 2023.
  9. ^ "Ritlecitinib". Inxight Drugs. Archived from the original on 25 June 2023. Retrieved 24 June 2023.
  10. ^ Ramírez-Marín HA, Tosti A (February 2022). "Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata". Drug Design, Development and Therapy. 16: 363–374. doi:10.2147/DDDT.S334727. PMC 8860347. PMID 35210753.
  11. ^ a b c d e f g h "Drug Trials Snapshots: Litfulo". U.S. Food and Drug Administration. 23 June 2023. Retrieved 29 April 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  12. ^ "FDA Approves Pfizer's Litfulo (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata" (Press release). Pfizer. 23 June 2023. Archived from the original on 25 June 2023. Retrieved 24 June 2023 – via Business Wire.
  13. ^ Kansteiner F (26 June 2023). "Pfizer's Litfulo enters the scene in alopecia with adolescent nod to rival Lilly's Olumiant". Fierce Pharma. Archived from the original on 8 July 2023. Retrieved 18 September 2023.

Further reading

[edit]
[edit]
Retrieved from "https://en.wikipedia.org/enwiki/w/index.php?title=Ritlecitinib&oldid=1250716554"