Pharmaceutical company Eli Lilly and Company (NYSE:LLY) on Friday announced a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Olumiant (baricitinib) for the treatment of adolescents with severe alopecia areata (AA), a chronic immune disease that causes hair loss.

Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly.

This positive opinion marks the next step toward European regulatory approval of Olumiant for adolescents aged 12 to under 18 with severe AA, and it is now referred to the European Commission for final action. A decision from the European Commission is expected in the next one to two months.

According to the company, the positive CHMP opinion is supported by 36-week data from the Phase 3 BRAVE-AA-PEDS study evaluating the safety and efficacy of once-daily, oral Olumiant compared with placebo in the cohort of patients ages 12 to under 18. Treatment with Olumiant helped many adolescents achieve near-complete scalp hair regrowth. Additionally, many patients achieved successful eyebrow and eyelash regrowth.

Lilly has also submitted Olumiant in the United States for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026.