The FDA has approved Sun Pharma’s oral JAK inhibitor, Leqselvi (deuruxolitinib), for the treatment of severe alopecia areata in adults.
The approval follows two successful phase 3 clinical trials demonstrating the drug's efficacy. The trials revealed that at baseline, the average patient had only 13% scalp hair coverage, which improved significantly, with one-third of patients achieving 80% or more scalp hair coverage after 24 weeks of treatment.
The multicenter, randomized, double-blind, placebo-controlled trials, THRIVE-AA1 and THRIVE-AA2, involved 1,220 patients with at least 50% scalp hair loss. The trials achieved their primary endpoint, with over 30% of patients treated with Leqselvi reaching 80% or more scalp hair coverage. Additionally, up to 25% of patients regained almost all their scalp hair.
Alopecia areata is an autoimmune disorder affecting approximately 700,000 people in the United States, with 300,000 cases classified as severe. The condition results in sudden hair loss due to the immune system attacking hair follicles, leading many sufferers to seek self-treatment due to dissatisfaction with current therapies.
Leqselvi, a twice-daily oral selective inhibitor of Janus Kinases (JAK) 1 and 2, interrupts the pathways contributing to hair loss, offering a new option for those with severe alopecia areata.
