Olumiant gains adolescent indication for severe alopecia areata

FDA has approved Olumiant (baricitinib) for adolescents aged 12 years and older with severe alopecia areata (AA), expanding the oral Janus kinase (JAK) inhibitor's indication beyond adults. The approval provides clinicians with another FDA-approved treatment option for adolescents with severe AA, a chronic autoimmune disease that can cause extensive scalp, eyebrow, and eyelash hair loss.

The decision was supported by results from the phase 3 BRAVE-AA-PEDS trial, the first and largest study specifically designed to evaluate adolescents with severe AA. At 36 weeks, treatment with once-daily Olumiant delivered:

• 80% or more scalp hair coverage in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo.
• 90% or more scalp hair coverage in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo.
• Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg.

These findings suggest that meaningful hair regrowth is achievable for many adolescents with severe disease, including patients who entered the trial with complete scalp hair loss and had been living with AA for more than six years on average.

The safety profile in adolescents was consistent with the safety profile previously reported in adults with severe AA. Olumiant carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Common adverse events include upper respiratory tract infections, headache, acne, increased cholesterol levels, urinary tract infections, elevated liver enzymes, folliculitis, fatigue, and nausea.

"Alopecia areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones," said George Gondo, chief mission officer of the National Alopecia Areata Foundation. "More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."

Sources: Lilly. (2026 Sep 25). FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata; National Alopecia Areata Foundation. (2026 Sep 28). FDA expands approval of Olumiant for adolescents with severe alopecia areata