Olumiant (baricitinib) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of adolescents aged 12 to under 18 with severe alopecia areata. The decision, announced on February 27, 2026, follows the Phase 3 BRAVE‑AA‑PEDS study, in which 42% of patients achieved 80% or more scalp hair coverage at 36 weeks, a benchmark that demonstrates meaningful clinical benefit for a population with limited therapeutic options.
The approval expands Olumiant’s indication beyond the adult population, opening a new market segment that is both sizable and underserved. For Incyte, the company that discovered the drug and licenses it to Eli Lilly, the expansion strengthens its dermatology franchise and adds a new revenue stream that complements its core oncology and hematology products. Eli Lilly, which has been building a robust portfolio in immunology and dermatology, gains a broader patient base for a product that already generates significant licensing income.
"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," said Anabela Cardoso, senior vice president of Lilly Immunology Medical Affairs. "The depth and rigor of data from BRAVE‑AA‑PEDS – the first and largest trial designed specifically for these young patients – reflects Lilly's longstanding commitment to advancing care for people with chronic skin diseases who have had limited options for far too long."
The CHMP recommendation is a formal step toward European Commission approval, which is expected within one to two months. In parallel, Incyte and Eli Lilly have submitted the adolescent indication to the U.S. Food and Drug Administration, with a decision anticipated in the second half of 2026. The dual‑region regulatory pathway underscores the companies’ commitment to delivering the therapy to patients worldwide as quickly as possible.
The broader alopecia areata treatment market is growing, driven by increasing awareness and the emergence of Janus kinase (JAK) inhibitors as a new class of effective therapies. Olumiant’s success in adolescents positions it competitively against other JAK inhibitors and emerging biologics, and it may serve as a platform for future indications in related autoimmune skin disorders. The positive opinion therefore not only expands the current market but also signals a strategic foothold for both Incyte and Eli Lilly in a rapidly evolving therapeutic area.
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