Eli Lilly and Company and Incyte have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending expanded use of Olumiant (baricitinib) to treat adolescents aged 12 to under 18 years with severe alopecia areata (AA) in the European Union. AA is described as a chronic immune disease that can cause extensive and unpredictable hair loss and can have a particularly severe social and emotional impact on young patients and their families.
The CHMP recommendation is based on 36‑week data from the Phase 3 BRAVE‑AA‑PEDS trial, the first and largest study specifically designed to evaluate children and adolescents with severe AA. In the trial, 42.4% of patients receiving 4 mg of once‑daily oral Olumiant and 27.4% of those receiving 2 mg achieved at least 80% scalp hair coverage at 36 weeks, compared with 4.5% on placebo. Near‑complete (at least 90%) scalp hair coverage was reported in 36.5% and 21.4% of patients on 4 mg and 2 mg, respectively, versus 2.3% on placebo.
The company reported that many adolescents also achieved significant eyebrow and eyelash regrowth, with eyebrow regrowth seen in 50.0% (4 mg) and 24.1% (2 mg) versus 0% on placebo, and eyelash regrowth in 42.9% (4 mg) and 25.5% (2 mg) versus 14.0% on placebo. The safety profile in adolescents with AA was said to be consistent with that observed in trials in juvenile idiopathic arthritis and moderate‑to‑severe atopic dermatitis.
Olumiant, a once‑daily oral JAK inhibitor discovered by Incyte and licensed to Lilly, is already approved by the European Commission and the U.S. Food and Drug Administration for adults with severe AA. The CHMP opinion will now be referred to the European Commission, with a decision expected in the next one to two months. Lilly has also submitted Olumiant in the U.S. for adolescent severe AA, with a decision anticipated in the second half of 2026.
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