Health
Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata
Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) 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
About this update from Eli Lilly And Company
[{"type":"text","content":"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","length":195,"tagName":"p","attribs":{}},{"type":"text","content":"The study is the first and largest of its kind specifically designed to evaluate children and adolescents with severe AA, a disease that has devastating social and emotional impact","length":180,"tagName":"p","attribs":{}},{"type":"text","content":"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","length":150,"tagName":"p","attribs":{}},{"type":"text","content":"INDIANAPOLIS, Feb. 27, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) 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","length":590,"tagName":"p"},{"type":"text","content":""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, 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."","length":574,"tagName":"p"},{"type":"text","content":"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 Europ...