CHMP Recommends Olumiant for Adolescents with Severe Alopecia Areata After 42.4% Hair Regrowth
CHMP issued a positive opinion for Lilly’s Olumiant to treat adolescents (12–17) with severe alopecia areata, as Phase 3 BRAVE-AA-PEDS data showed 42.4% on 4 mg reached ≥80% scalp hair coverage versus 4.5% on placebo at 36 weeks. European approval is expected in two months, U.S. approval is due in H2 2026.
1. CHMP Positive Opinion on Adolescent Use
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Olumiant (baricitinib) for adolescents aged 12 to under 18 with severe alopecia areata. This recommendation marks the first regulatory step for expanding Olumiant’s indication beyond adult patients to a younger population with high unmet need.
2. Phase 3 BRAVE-AA-PEDS Trial Results
BRAVE-AA-PEDS enrolled adolescent patients weighing ≥30 kg in a 1:1:1 randomization to placebo, Olumiant 2 mg or 4 mg. At Week 36, 42.4% of those on 4 mg and 27.4% on 2 mg achieved ≥80% scalp hair coverage compared to 4.5% on placebo. Near-complete regrowth (≥90% coverage) occurred in 36.5% (4 mg) and 21.4% (2 mg), with significant eyebrow and eyelash regrowth also reported.
3. Regulatory Timeline and Next Steps
The positive CHMP opinion is now referred to the European Commission, which is expected to issue a final decision within one to two months. Lilly has also submitted U.S. approval for the adolescent alopecia areata indication, with a decision anticipated in the second half of 2026.