FDA Approves Oral JAK Inhibitor for Alopecia

The FDA has approved Leqselvi (deuruxolitinib) tablets to treat adults with severe alopecia areata.

Alopecia areata affects about 700,000 people in the United States, and 300,000 have 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 is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss,” Nicole Friedland, president and CEO, National Alopecia Areata Foundation (NAAF), said in a news release.

Developed by Sun Pharmaceutical, Leqselvi is a twice- daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. Previous studies have suggested that the JAK pathway contributes to hair loss in severe alopecia areata.

Sun Pharmaceutical has not provided information about when Leqselvi will be available or what the list price will be.

The approval is based on data from two 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 for 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 based on the Severity of Alopecia Tool (SALT). 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).

Posters presented at the 2024 American Academy of Dermatology Annual Meeting confirmed the efficacy and successful tolerability of deuruxolitinib, according to reporting in the American Journal of Managed Care.

One poster focused on the efficacy of deuruxolitinib among adult patients aged 18 to 65 years from the two trials. The studies consisted of a placebo group, a group receiving 8 mg of deuruxolitinib twice daily, and a group receiving 12 mg of deuruxolitinib twice daily under a 24-week treatment period and 4-week safety follow-up. Statistically significant improvements in scalp hair regrowth were achieved with both doses of deuruxolitinib from as early as week 4.

Another poster depicted a pooled safety assessment from both trials. A total of 88 patients experienced treatment discontinuation. Treatment-emergent adverse events (TEAEs) or worsening adverse events were the main reasons for treatment discontinuation but were low overall.

The poster suggested more than 95% of treatment-emergent adverse events were mild to moderate in patient severity with no meaningful treatment group trends related to vital signs or electrocardiogram results. Similar incidence and severity of adverse events were found among both deuruxolitinib dose groups.