Is Leqselvi (Deuruxolitinib) on the market?

On July 26, 2024, Leqselvi (Deuruxolitinib) produced by IndiaSun Pharmaceutical Industries Inc was approved by the US Food and Drug Administration (FDA). The 8 mg tablet form can be used to treat severe alopecia areata (AA) in adults, with the trade name Leqselvi. Alopecia areata is an autoimmune disease with physical, emotional and financial consequences that go far beyond hair loss. The launch of this drug provides another important option for those suffering from severe alopecia areata.

The FDA's marketing 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 experienced at least 50% scalp hair loss as measured by the Severity of Hair Loss Tool (SALT) over six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll after completing 24 weeks of the trial.

At study baseline, the average patient had only 13% scalp hair coverage. In the trial, the primary endpoint was met at week 24, with more than 30% of patients taking LEQSELVI experiencing 80% or greater scalp hair coverage (SALT ≤ 20). The number of patients taking Leqselvi and achieving SALT ≤20 showed a continued upward trend, with no plateau at 24 weeks. Additionally, up to 25% of patients had almost complete scalp hair restoration (≥90% coverage) by week 24.

In both the Phase 2 dose-ranging study and the Phase 3 randomized placebo-controlled trial, a small number (3.1%) of patients taking Leqselvi 8 mg twice daily withdrew due to adverse reactions. In clinical trials, more than 100 people continued taking Leqselvi for more than three years.