Key insights
- The FDA has approved Eli Lilly's Olumiant (baricitinib) for adolescents aged 12 and older with severe alopecia areata. This expands the drug's U.S. label beyond adult use. The approval is based on Phase 3 trial data showing significant hair regrowth in pediatric patients. Olumiant is a JAK inhibitor also approved for rheumatoid arthritis and COVID-19.
Eli Lilly and Company (LLY) said the U.S. Food and Drug Administration approved Olumiant (baricitinib) as a once-daily oral treatment for patients 12 years of age and older with severe alopecia areata (AA), expanding the drug’s existing U.S. label beyond adult use.
The approval is based on 36-week data from the BRAVE-AA-PEDS Phase 3 trial, which enrolled adolescents ages 12 to under 18. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.
At week 36, 42% of patients receiving Olumiant 4 mg and 27% receiving Olumiant 2 mg achieved at least 80% scalp hair coverage, compared with 5% in the placebo group. At least 90% scalp hair coverage was achieved by 37% of patients on 4 mg and 21% on 2 mg, versus 2% on placebo. Patients treated with the 4 mg dose also showed improved eyebrow and eyelash coverage.
The recommended starting dose is 2 mg per day, with an option to increase to 4 mg if response is inadequate. The FDA-approved labeling includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Lilly said the safety profile observed in the pediatric population was consistent with that seen in adults with severe AA. The European Commission approved the same indication in April 2026.
Olumiant is a JAK inhibitor originally discovered by Incyte and licensed to Lilly under an agreement established in December 2009. The drug is currently approved in more than 75 countries for adults with moderately to severely active rheumatoid arthritis and is also approved in the U.S. for hospitalized adults with COVID-19. Since 2017, more than 33,000 patients have been prescribed Olumiant in the U.S., according to the company.
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