Sun Pharmaceutical Industries Ltd. received approval from the FDA for LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.

Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. Alopecia areata affects around 700,000 people in the U.S., and 300,000 have severe alopecia areata. 

LEQSELVI is a twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata.

The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 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. 

At study baseline, the average patient had only 13% of their scalp hair coverage. In the trials, at 24 weeks, the primary endpoint was met, with more than 30% of patients taking LEQSELVI experiencing 80% or more scalp hair coverage. Additionally, up to 25% of patients had almost all of their scalp hair back at 24 weeks.