India-based specialty generics company with a presence in specialty, generics, and consumer healthcare products Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for its LEQSELVI (deuruxolitinib) eight mg tablets intended for the treatment of adults with severe alopecia areata.

LEQSELVI received approval based on data from two multicentre, randomised, double-blind, placebo-controlled Phase three clinical trials THRIVE-AA1 and THRIVE-AA2. The study enrolled a total of 1,220 patients with alopecia areata who had around 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for over six months. The study also collected data from two open-label, long-term extension trials, in which patients were eligible to enrol after completion of the 24-week trials.

Abhay Gandhi, Sun Pharma's North America Business CEO, said, 'LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians. Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.'

Nicole Friedland, National Alopecia Areata Foundation (NAAF) president and CEO, said, 'We welcome the approval of LEQSELVI as a significant step for the alopecia areata community. Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata.'