Eli Lilly and Company and Incyte announced today that the European Medicines Agency’s (EMA) 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).
AA is a chronic immune disease that can have an especially devastating social and emotional impact on young patients and their families, as early onset AA can be more severe and lead to extensive and unpredictable hair loss.1
Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the European Commission (EC) and U.S. Food and Drug Administration (FDA) approved Olumiant for adult patients with severe AA, making it the first JAK inhibitor approved in these geographies for severe disease.
This positive opinion marks the next step toward European regulatory approval of Olumiant for adolescents ages 12 to under 18 with severe AA, and it is now referred to the European Commission for final action. The European Commission’s decision is expected in the next one to two months.
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.2
| Efficacy results at 36 weeks2 | |||
| Dose: 4 mg | Dose: 2 mg | Placebo | |
| Successful (≥80%) scalp hair coverage* | 42.4 % | 27.4 % | 4.5 % |
| Near-complete (≥90%) scalp hair coverage† | 36.5 % | 21.4 % | 2.3 % |
| Significant eyebrow regrowth‡ | 50.0 % | 24.1 % | 0 % |
| Eyelash regrowth‡ | 42.9 % | 25.5 % | 14.0 % |
| * Severity of Alopecia Tool (SALT) score ≤20 |
| † SALT score ≤10 |
| ‡ Clinician-reported outcome (ClinRO) score of 0 or 1 with a ≥2-point improvement from baseline |
The safety profile of Olumiant in adolescents with AA was consistent with the safety profile seen in clinical trials for children with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.2
In addition, 52-week efficacy and safety data demonstrating successful hair regrowth on the scalp, eyebrows and eyelashes in adolescent patients were also recently presented at the Fall Clinical Dermatology (FCD) Conference in October 2025.
Olumiant is the most-researched JAK inhibitor in AA. In total for all indications, more than 14,600 patients have received Olumiant in completed and ongoing clinical trials. Of these, over 1,200 have been children and adolescents.
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.
Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the US and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries outside the US for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in the US, Europe and Japan for adult patients with severe AA. Marketing authorisation for the treatment of hospitalised patients with COVID-19 has been granted for baricitinib in multiple countries.
The US FDA-approved labelling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
References were supplied.
