FDA OKs First Systemic Treatment for Alopecia Areata

The US Food and Drug Administration (FDA) today approved baricitinib oral tablets as the first systemic treatment for adult patients with severe alopecia areata.

The disorder with the hallmark signs of patchy baldness affects millions of people each eyar. In patients with the autoimmune disorder, the body attacks its own hair follicles and hair falls out, often in clumps. In February, the FDA granted priority review for baricitinib in adults with severe AA.

Baricitinib (Olumiant) is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more enzymes, interfering with the pathway that leads to inflammation.

Evidence from Two Trials Led to Announcement

This week's decision came after review of the results from two randomized, double-blind, placebo-controlled trials (BRAVE AA-1 and BRAVE AA-2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT score) for more than 6 months.

Patients in these trials got either a placebo, 2 mg of baricitinib or 4 mg of baricitinib every day. The primary endpoint for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

Baricitinib was originally approved in 2018 as a treatment for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF)-blockers. It is also approved for treating COVID-19 in certain hospitalized adults.

Until now, the only treatments for moderate to severe AA approved by the FDA have been intralesional steroid injections, contact sensitization, and systemic immunosuppressants, but they have demonstrated limited efficacy, are inconvenient for patients to take, and have been unsuitable for use long term.

Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of baricitinib for adults with severe AA.

AA received widespread international attention earlier this year at the Academy Awards ceremony, when actor Will Smith walked from the audience up onto the stage and slapped comedian Chris Rock in the face after he directed a joke at Smith's wife, Jada Pinkett Smith, for her shaved head. Pinkett Smith has AA and has been public about her struggles with the disease.