Deuruxolitinib FDA Approved for Severe Alopecia Areata in Adults

The US Food and Drug Administration (FDA) has approved deuruxolitinib (LEQSELVI) 8 mg tablets for the treatment of adults with severe alopecia areata, a condition affecting approximately 300,000 individuals in the United States.

Deuruxolitinib is an oral, twice-daily, selective inhibitor of JAK1 and JAK2. It works by interrupting the pathways that contribute to hair loss in severe alopecia areata. This approval follows data from 2 multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which enrolled 1220 patients with alopecia areata who had at least 50% scalp hair loss for more than 6 months.

In these trials, patients taking deuruxolitinib experienced significant improvements in scalp hair coverage. At 24 weeks, over 30% of patients achieved 80% or more scalp hair coverage, with up to 25% having almost all of their scalp hair back (≥90% coverage). The efficacy of deuruxolitinib showed a consistent upward trend with no plateau through 24 weeks.

The safety profile of deuruxolitinib was assessed through the 24-week treatment period and long-term extension trials. The most common adverse events included headache (12.4% with deuruxolitinib vs 9.4% with placebo), acne (10% with deuruxolitinib vs 4.3% with placebo), and nasopharyngitis (8.1% with deuruxolitinib vs 6.7% with placebo). Serious side effects may include infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Deuruxolitinib should not be used in patients who are CYP2C9 poor metabolizers or those taking moderate or strong CYP2C9 inhibitors.

"We welcome the approval of [deuruxolitinib] as a significant step for the alopecia areata community," said Nicole Friedland, president and CEO of the National Alopecia Areata Foundation. "This new treatment option provides hope and additional choices for those living with severe alopecia areata."

Reference

FDA approves LEQSELVI (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata. News release. Sun Pharmaceutical Industries Limited. July 25, 2024. Accessed July 30, 2024.