FDA Approves Leqselvi for Severe Alopecia
By Lori Solomon HealthDay Reporter
FRIDAY, Aug. 2, 2024 -- The U.S. Food and Drug Administration has approved Leqselvi (deuruxolitinib) tablets for the treatment of adults with severe alopecia areata.
Leqselvi (8 mg) is a twice-daily oral selective inhibitor of the Janus kinases JAK1 and JAK2. In trials, the three most common adverse events were headache, acne, and nasopharyngitis.
The approval was based on data from the THRIVE-AA1 and THRIVE-AA2 randomized, double-blind, placebo-controlled phase 3 clinical trials, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 percent scalp hair loss for more than six months. Over 24 weeks, more than 30 percent of patients taking Leqselvi experienced ≥80 percent scalp hair coverage (Severity of Alopecia Tool [SALT] ≤20). Up to one-quarter of patients had almost all of their scalp hair back at 24 weeks (≥90 percent coverage). The number of Leqselvi-treated patients achieving a SALT score ≤20 did not plateau through 24 weeks.
"For many people with severe alopecia areata, early intervention with effective treatment is critical," Natasha Mesinkovska, M.D., Ph.D., from the University of California, Irvine, and an investigator in the Leqselvi clinical development program, said in a statement. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."
Approval of Leqselvi was granted to Sun Pharma.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted August 2024
Read this next
Childhood Obesity Tied to Pediatric Immune-Mediated Skin Diseases
TUESDAY, Aug. 27, 2024 -- Early childhood obesity may increase the risk for pediatric immune-mediated skin diseases, according to a study published online Aug. 21 in...
Alopecia Tied to Higher Prevalence of Autoimmune, Psychiatric Comorbidities
TUESDAY, Aug. 6, 2024 -- Patients with alopecia areata (AA) have a higher prevalence of autoimmune and psychiatric comorbidities at time of diagnosis as well as a higher risk for...
AAD: Continuous Improvements Seen Through 68 Weeks for Deuruxolitinib in Alopecia
TUESDAY, March 19, 2024 -- For adults with alopecia areata, continuous improvements are seen through 68 weeks with deuruxolitinib, according to a study presented at the annual...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.