Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata
Shots:
- The US FDA has granted approval to the company’s Leqselvi (8mg) tablets for treating severe alopecia areata adults
- Approval was supported by two P-III (THRIVE-AA1 & THRIVE-AA2) studies that assessed the scalp hair regrowth using the SALT score with Leqselvi (8mg or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata post 24wks. across the US, Canada & EU
- Avg. patients had 13% of scalp hair coverage at baseline. Study reached the 1EP, showing ≥80% scalp hair coverage (SALT ≤20) among 30% of patients with a consistent upward trend & no plateau after 24wks.; ~25% regained their scalp hair (≥90% coverage)
Ref: Sun Pharma | Image: Sun Pharma| Press Release
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