USFDA approves Sun Pharma's drug to treat alopecia areata

New Delhi: Sun Pharmaceutical Industries Ltd on Friday said the US health regulatory has approved its LEQSELVI (deuruxolitinib) drug for the treatment of adults with severe alopecia areata.

The approval by the US Food and Drug Administration (USFDA) is for LEQSELVI (deuruxolitinib) 8 mg tablets, Sun Pharma said in a regulatory filing.

Alopecia areata is an autoimmune disorder that can lead to unpredictable hair loss. It occurs when the immune system mistakenly targets hair follicles on the scalp, face, and sometimes other parts of the body, due to a breakdown in immune 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 said.

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