Ritlecitinib
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| Trade names | Litfulo |
| Other names | PF-06651600 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624015 |
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| Routes of administration | By mouth |
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| Formula | C15H19N5O |
| Molar mass | 285.351 g·mol−1 |
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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]Legal status
[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]- ^ a b "Litfulo (ritlecitinib)". Therapeutic Goods Administration (TGA). 30 July 2024. Retrieved 12 October 2024.
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/litfulo-pfizer-australia-pty-ltd
- ^ "Litfulo Product information". Health Canada. 13 February 2024. Retrieved 3 March 2024.
- ^ a b c "Summary Basis of Decision for Litfulo". Health Canada. 18 July 2024. Retrieved 28 August 2024.
- ^ "Regulatory Decision Summary for Litfulo". Health Canada. 29 November 2023. Retrieved 2 April 2024.
- ^ 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.
- ^ a b c d "Litfulo EPAR". European Medicines Agency. 18 September 2023. Archived from the original on 19 September 2023. Retrieved 20 September 2023.
- ^ "Litfulo Product information". Union Register of medicinal products. 18 September 2023. Archived from the original on 1 October 2023. Retrieved 1 October 2023.
- ^ "Ritlecitinib". Inxight Drugs. Archived from the original on 25 June 2023. Retrieved 24 June 2023.
- ^ 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.
- ^ 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.
This article incorporates text from this source, which is in the public domain.
- ^ "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.
- ^ 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]- Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, et al. (April 2022). "Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers". The Journal of Allergy and Clinical Immunology. 149 (4): 1318–1328. doi:10.1016/j.jaci.2021.10.036. PMID 34863853. S2CID 244824663.
- King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, et al. (May 2023). "Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial". Lancet. 401 (10387). London, England: 1518–1529. doi:10.1016/S0140-6736(23)00222-2. PMID 37062298. S2CID 258114404.
External links
[edit]- Clinical trial number NCT03732807 for "PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)" at ClinicalTrials.gov
