Sun Pharma hair loss drug gets FDA approval

Sun Pharma has announced that its oral JAK inhibitor, Leqselvi (deuruxolitinib), has received approval from the FDA for treating severe alopecia areata in adults. This approval is based on the positive outcomes from two phase 3 clinical trials that showcased the drug's effectiveness.

In these trials, the average patient initially had only 13% scalp hair coverage. However, after 24 weeks of treatment with Leqselvi, there was a significant improvement, with one-third of the patients achieving 80% or more scalp hair coverage. These studies, known as THRIVE-AA1 and THRIVE-AA2, were comprehensive, multicenter, randomized, double-blind, and placebo-controlled, including 1,220 participants who had lost at least 50% of their scalp hair. The trials met their primary endpoint, with over 30% of patients treated with Leqselvi reaching 80% or more scalp hair coverage. Additionally, nearly a quarter of the patients regained almost all their scalp hair.

Alopecia areata, an autoimmune condition, affects around 700,000 individuals in the United States, with 300,000 of these cases being severe. This disorder leads to sudden hair loss as the immune system mistakenly targets hair follicles. The sudden nature of hair loss drives many individuals to seek self-treatment due to dissatisfaction with existing therapies.

Leqselvi operates as a selective Janus Kinase (JAK) 1 and 2 inhibitor, administered twice daily. It functions by disrupting the pathways that contribute to hair loss, offering a novel treatment solution for those suffering from severe alopecia areata.