Eli Lilly and Company (LLY) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant to treat adolescents aged 12 to under 18 years with severe alopecia areata, a chronic immune disease.
The European Commission's decision is expected within one to two months.
The opinion is supported by data from the Phase 3 BRAVE-AA-PEDS study, in which Olumiant demonstrated significant scalp hair regrowth compared with placebo, with many patients also achieving eyebrow and eyelash regrowth.
Olumiant is also under review in the United States for severe alopecia areata in adolescents, with a decision expected in the second half of 2026.
Olumiant, discovered by Incyte and licensed to Eli Lilly and Company, is approved for the treatment of adults with severe alopecia areata in the United States, the European Union, Japan, Canada and several other countries. The drug is also approved in more than 75 countries for various autoimmune and inflammatory conditions.
Lilly closed Thursday's trading at $1,022.02, down 0.66%.
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