CHMP Recommends Olumiant for Adolescents with Severe Alopecia Areata in the EU

Positive opinion based on Phase 3 BRAVE-AA-PEDS trial supports first-in-class JAK inhibitor therapy for young patients with profound hair loss.

The CHMP has issued a positive opinion for Olumiant (baricitinib) for adolescents with severe alopecia areata, following Phase 3 BRAVE-AA-PEDS data showing 42% achieved ≥80% scalp hair coverage at 36 weeks.

If approved by the European Commission, Olumiant will offer the first evidence-based therapy specifically for this vulnerable population, addressing significant social and emotional impact of early-onset AA.

Alert Type	Drug Approval (CHMP positive opinion)
Drug/Device Name	Olumiant (baricitinib)
Indication	Treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA)
Therapy Area(s)	Dermatology / Immunology
Geography	EU (EMA / CHMP)
What Changed	CHMP issued a positive opinion recommending Olumiant for approval in adolescents with severe AA, based on the Phase 3 BRAVE-AA-PEDS trial showing 42% of patients achieved ≥80% scalp hair coverage at 36 weeks. The opinion will now be reviewed by the European Commission for final approval.
Clinical Relevance	Provides a first-in-class JAK inhibitor therapy for adolescents with severe AA, a population with limited treatment options, supporting hair regrowth on the scalp, eyebrows, and eyelashes while maintaining a manageable safety profile.
Source Link	PR Newswire / GlobalData
Date	27-Feb-2026
Status	Draft
Notes	BRAVE-AA-PEDS is the first and largest Phase 3 trial for adolescents with severe AA; efficacy includes scalp, eyebrow, and eyelash regrowth; U.S. submission is pending with decision expected H2 2026.

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