Sun Pharma's Hair Loss Drug Approved by USFDA

26 Jul 2024 , 01:45 PM

Sun Pharmaceutical Industries Ltd announced on Friday that its LEQSELVI (deuruxolitinib) medicine has been authorised by the US FDA for the treatment of adults with severe alopecia areata. The US Food and Drug Administration (USFDA) has approved LEQSELVI (deuruxolitinib) 8 mg tablets, according to a regulatory filing by Sun Pharma.

Alopecia areata is an autoimmune condition that causes unpredictable hair loss. It happens when the immune system mistakenly targets hair follicles on the scalp, face, and occasionally other parts of the body as a result of a breakdown in immunological privilege.

“LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians,” Sun Pharma CEO, North America Business, Abhay Gandhi, stated.

The approval is based on data from two multicenter, randomised, double-blind, placebo-controlled Phase 3 clinical trials involving 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months, according to the company.

For feedback and suggestions, write to us at [e-mail]