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The FDA approved the oral Janus kinase (JAK) inhibitor to treat alopecia areata, drugmaker Sun Pharmaceutical announced on Thursday.

The approval stipulates use of deuruxolitinib in adults with severe alopecia areata. The JAK1/2 inhibitor is the third oral JAK inhibitor approved for alopecia areata in the past 2 years, following baricitinib (Olumiant) and ritlecitinib (Litfulo), the latter of which has approval for patients ages 12 and older.

"For many people with severe alopecia areata, early intervention with effective treatment is critical," said Natasha Mesinkovska, MD, PhD, of the University of California Irvine, in a statement from Sun Pharmaceutical. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."

The National Alopecia Areata Foundation (NAAF) also applauded the approval.

"Alopecia areata is an autoimmune disease, with significant physical, emotional, and financial impacts that go beyond hair loss," said Nicole Friedland, president and CEO of NAAF, in the company's statement. "Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata."

Principal support for the approval came from two phase III, randomized, placebo-controlled trials, and THRIVE-AA2, which involved a combined total of 1,220 patients with severe alopecia areata, defined as at least 50% scalp hair loss for 6 months or longer. Additional data came from two long-term extension trials.

At enrollment, patients in the two trials had an average 13% scalp hair coverage, determined by the Severity of Alopecia Tool (SALT). After 24 weeks, more than 30% of patients met the primary endpoint of scalp hair coverage ≥80% (SALT ≤20). One-fourth of patients had almost complete regrowth of hair at 24 weeks (≥90%).

Across the phase II and phase III clinical trials, 3.1% of patients discontinued deuruxolitinib because of adverse events (AEs) at the recommended dose of 8 mg twice daily. The most common AEs were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3%), and nasopharyngitis (8.1% vs 6.7%).

Deuruxolitinib may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Prescribing information includes a about potentially serious side effects.

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