EMA Panel Backs Baricitinib for Adolescents With Severe Alopecia Areata
Key Takeaways
The EMA’s CHMP has recommended expanding approval of baricitinib to adolescents aged 12 to younger than 18 years with severe alopecia areata.
In the Phase 3 BRAVE-AA-PEDS trial, 42.4% of adolescents receiving baricitinib 4 mg achieved ≥80% scalp hair coverage at 36 weeks vs 4.5% with placebo.
A European Commission decision is expected within 1 to 2 months; a US FDA decision is anticipated in the second half of 2026.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of baricitinib (Olumiant, Eli Lilly and Company), a once-daily oral Janus kinase (JAK) inhibitor, for adolescents aged 12 to younger than 18 years with severe alopecia areata (AA). The decision is based on data from the Phase 3 BRAVE-AA-PEDS trial, the first large-scale study designed specifically to evaluate children and adolescents with severe AA.
In BRAVE-AA-PEDS, treatment with baricitinib 4 mg resulted in 42.4% of patients achieving at least 80% scalp hair coverage (Severity of Alopecia Tool [SALT] score ≤20) at 36 weeks compared with 4.5% in the placebo group. Near-complete scalp hair regrowth (SALT score ≤10) occurred in 36.5% of patients receiving 4 mg and 21.4% receiving 2 mg, vs 2.3% with placebo. Clinician-reported outcomes also demonstrated eyebrow regrowth in 50.0% of patients treated with 4 mg vs 0% with placebo, and eyelash regrowth in 42.9% vs 14.0%, respectively.
The safety profile in adolescents was reported to be consistent with that observed in pediatric trials of baricitinib for juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis. Baricitinib was previously approved in 2022 by both the European Commission and the US Food and Drug Administration for adults with severe AA.
The CHMP opinion has been referred to the European Commission for final review, with a decision expected in the coming months. Lilly has also submitted a supplemental application to the FDA seeking approval for adolescent patients, with regulatory action anticipated later in 2026.