Global pharma powerhouse Eli Lilly and Incyte have announced a major regulatory milestone today: the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) to treat adolescents aged 12 to <18 with severe alopecia areata (AA).

 

AA, a chronic immune disease, can cause extensive and unpredictable hair loss, taking a profound social and emotional toll on young patients and their families. Early onset often leads to more severe outcomes.

 

"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."

 

Olumiant, a once-daily oral JAK inhibitor discovered by Incyte and licensed to Lilly, was first approved in 2022 by both the European Commission (EC) and U.S. Food and Drug Administration (FDA) for adults with severe AA. This latest CHMP endorsement moves Olumiant closer to European approval for adolescents, with the European Commission expected to make a final decision in one to two months.

 

The recommendation is backed by 36-week data from the Phase 3 BRAVE-AA-PEDS study, showing that many adolescents achieved near-complete scalp hair regrowth, as well as significant eyebrow and eyelash restoration. Safety data aligned with previous trials in juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.

 

52-week efficacy and safety results, recently presented at the Fall Clinical Dermatology Conference in October 2025, further reinforced Olumiant’s benefits for adolescents. Overall, Olumiant is the most-researched JAK inhibitor in AA, with over 14,600 patients across trials, including more than 1,200 children and adolescents.

 

"Adolescents with severe alopecia areata represent a particularly vulnerable population, as the disease is difficult to manage and occurs at a time when appearance can have a significant impact on social identity and emotional well-being," said Thierry Passeron, professor and chair, Department of Dermatology, Université Côte d'Azur. 

 

"In clinical practice, families are frequently left with limited options that fall short. If approved in the European Union, Olumiant will represent an important evidence-based treatment option for these young patients — and with it, the hope that more adolescents living with severe alopecia areata can be helped."