Ritlecitinib

From WikiProjectMed
Jump to navigation Jump to search
Ritlecitinib
Names
Trade namesLitfulo
Other namesPF-06651600
  • 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one
Clinical data
Routes of
use		By mouth
External links
AHFS/Drugs.comMonograph
MedlinePlusa624015
Legal
License data
Legal status
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 to treat a type of hair loss known as alopecia areata.[6] It is taken by mouth.[6] It may be used in those over the age of 12 with severe disease.[4] At least moderate improvement occur in about 50% compared to 10% with placebo.[4]

Common side effects include headache, diarrhea, acne, rashes including eczema, fever, mouth ulcers, dizziness, shingles, and anemia.[6] Serious side effects may include infections and blood clots.[6] Live vaccines should not be taken by those on this medication.[6] It is not recommend in breastfeeding or those with liver problems.[6] It is a kinase inhibitor which inhibits Janus kinase 3 and tyrosine kinase.[6]

Ritlecitinib was approved for medical use in the United States and Europe in 2023,[6][4] and in Canada in 2024.[2] In the United States it costs about 4,000 USD per month as of 2024 while this amount costs about £900 in the United Kingdom.[7][8]

Medical uses

Ritlecitinib is indicated for the treatment of severe alopecia areata for individuals twelve years of age and older.[6][4]

Dosage

It is typically used at a dose of 50 mg once per day.[6]

History

The FDA approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata.[9] 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.[9] The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens.[9] 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.[9] 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.[9]

Society and culture

Economics

The annual list price of a prescription is US$49,000.[10]

References

  1. ↑ "Litfulo Product information". Health Canada. 13 February 2024. Archived from the original on 3 March 2024. Retrieved 3 March 2024. Archived 3 March 2024 at the Wayback Machine
  2. ↑ 2.0 2.1 "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Archived from the original on 2024-03-02. Retrieved 2 March 2024. Archived 2024-03-02 at the Wayback Machine
  3. ↑ "Regulatory Decision Summary for Litfulo". Drug and Health Products Portal. 29 November 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024. Archived 2 April 2024 at the Wayback Machine
  4. ↑ 4.0 4.1 4.2 4.3 4.4 "Litfulo EPAR". European Medicines Agency. 18 September 2023. Archived from the original on 19 September 2023. Retrieved 20 September 2023. Archived 19 September 2023 at the Wayback Machine
  5. ↑ "Litfulo Product information". Union Register of medicinal products. 18 September 2023. Archived from the original on 1 October 2023. Retrieved 1 October 2023. Archived 1 October 2023 at the Wayback Machine
  6. ↑ 6.00 6.01 6.02 6.03 6.04 6.05 6.06 6.07 6.08 6.09 6.10 "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. Archived 29 August 2023 at the Wayback Machine
  7. ↑ "Litfulo Prices, Coupons, Copay Cards & Patient Assistance". Drugs.com. Archived from the original on 19 June 2024. Retrieved 6 July 2024. Archived 19 June 2024 at the Wayback Machine
  8. ↑ "Ritlecitinib for treating severe alopecia areata in people 12 years and over". NICE. Archived from the original on 30 May 2024. Retrieved 6 July 2024. Archived 30 May 2024 at the Wayback Machine
  9. ↑ 9.0 9.1 9.2 9.3 9.4 "Drug Trials Snapshots: Litfulo". U.S. Food and Drug Administration. 23 June 2023. Archived from the original on 7 July 2024. Retrieved 29 April 2024. Archived 7 July 2024 at the Wayback Machine Public Domain This article incorporates text from this source, which is in the public domain.
  10. ↑ 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. Archived 8 July 2023 at the Wayback Machine

Further reading

External links

Identifiers:
Retrieved from "https://mdwiki.org/w/index.php?title=Ritlecitinib&oldid=1441237"