Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata

The positive opinion is based on data from the Phase 3 BRAVE-AA-PEDS study, in which 42% of patients with severe alopecia areata (AA) reached 80% or more scalp hair coverage at 36 weeks

Published on Mar. 2, 2026

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Eli Lilly and Company and Incyte announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA). The positive opinion is based on data from the Phase 3 BRAVE-AA-PEDS study, in which 42% of patients with severe AA reached 80% or more scalp hair coverage at 36 weeks. Lilly has also submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026.

Why it matters

Adolescents with severe alopecia areata represent a particularly vulnerable population, as the disease is difficult to manage and occurs at a time when appearance can have a significant impact on social identity and emotional well-being. If approved in the European Union, Olumiant will represent an important evidence-based treatment option for these young patients — and with it, the hope that more adolescents living with severe alopecia areata can be helped.

The details

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.

  • The European Commission's decision is expected in the next one to two months.
  • Lilly has submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026.

The players

Eli Lilly and Company

An American pharmaceutical company that discovered and licensed Olumiant (baricitinib) to Incyte.

Incyte

A Wilmington, Delaware-based, global biopharmaceutical company that discovered Olumiant (baricitinib) and licensed it to Eli Lilly and Company.

European Medicines Agency (EMA)

The regulatory body that oversees the approval of medicines in the European Union.

Committee for Medicinal Products for Human Use (CHMP)

The committee within the EMA that is responsible for evaluating and providing recommendations on the approval of medicines.

Thierry Passeron, M.D., PhD

A professor and chair of the Department of Dermatology at Université Côte d'Azur.

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What they’re saying

“The positive CHMP opinion supports the potential expansion of Olumiant as a new treatment option for adolescents living with the profound physical and emotional realities of severe alopecia areata.”

— Anabela Cardoso, Senior Vice President, Lilly Immunology Medical Affairs

“Adolescents with severe alopecia areata represent a particularly vulnerable population, as the disease is difficult to manage and occurs at a time when appearance can have a significant impact on social identity and emotional well-being. In clinical practice, families are frequently left with limited options that fall short. If approved in the European Union, Olumiant will represent an important evidence-based treatment option for these young patients — and with it, the hope that more adolescents living with severe alopecia areata can be helped.”

— Thierry Passeron, Professor and Chair, Department of Dermatology, Université Côte d'Azur

What’s next

The European Commission's decision on the approval of Olumiant for the treatment of adolescents with severe alopecia areata is expected in the next one to two months.

The takeaway

The positive CHMP opinion for Olumiant represents an important step forward in providing a new evidence-based treatment option for the vulnerable population of adolescents living with the profound physical and emotional impacts of severe alopecia areata, a disease that has historically had limited therapeutic options.