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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
