FDA approves Sun Pharma’s alopecia drug Leqselvi

Indian pharma major Sun Pharmaceutical Industries (BSE: 524715) saw its shares gain 3.3% to 1,721 rupees, on the news that the US Food and Drug Administration (FDA) had approved its Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe alopecia areata.

Approval of the oral JAK inhibitor is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase III clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

Alopecia areata affects around 700,000 people in the USA, and 300,000 have severe alopecia areata. Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments, Sun Pharma noted.