FDA Approves Sun Pharma's LEQSELVI for Severe Alopecia Areata

Sun Pharmaceutical Industries Limited has been approved by the U.S. Food and Drug Administration (FDA) for LEQSELVI™ (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata. Alopecia areata is an autoimmune disease that causes hair loss due to the collapse of immune privilege, leading to the immune system targeting hair follicles and causing sudden hair loss on the scalp, face, and sometimes other areas of the body. LEQSELVI is a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2.

The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled 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. At 24 weeks, the primary endpoint was met, with more than 30% of patients taking LEQSELVI experiencing 80% or more scalp hair coverage. Up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥90% coverage).

LEQSELVI may cause serious side effects including infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. It should not be used in patients who are CYP2CP poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Sun Pharma is committed to delivering support to the alopecia areata community and will introduce an access program to help eligible patients get started and stay on track with their treatment.