Sun Pharmaceutical Industries Limited Receives Approval from U.S. Food and Drug Administration for LEQSELVITM (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata

Sun Pharmaceutical Industries Limited informed that they have received approval from the U.S. Food and Drug Administration for LEQSELVITM (deuruxolitinib), an Oral JAK Inhibitor for the treatment of severe alopecia areata. Alopecia areata affects around 700,000 people in the United States, 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.

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. LEQSELVI is a new, 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 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. 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 (SALT 20). The number of patients taking LEQSELVI and achieving a SALT score of 20 showed a consistent upward trend with no plateau through 24 weeks. Additionally, up to 25% of patients had almost all of their scalp hair back at 24 weeks (90% coverage).

Across the Phase 2 dose-ranging study and Phase 3 randomized, placebo-controlled trials, few patients (3.1%) receiving LEQSELVI 8 mg twice daily were discontinued from the trials due to adverse reactions. In clinical trials, more than 100 people continued taking deuruxolitinib for more than three years.