Lilly’s Olumiant recommended for approval of expanded use for adolescents with severe alopecia areata

Eli Lilly and Incyte has recently announced that the EMA CHMP has issued a positive opinion for Olumiant for the treatment of adolescents with severe alopecia areata. 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.

“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.”

Note that Olumiant is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the European Commission and the U.S. FDA has approved Olumiant for adult patients with severe AA, making it the first JAK inhibitor approved in these geographies for this indication. This positive opinion marks the next step toward European regulatory approval of Olumiant for adolescents ages 12 to under 18 with severe AA, and it is now referred to the European Commission for final action.

In addition, this positive CHMP opinion is supported by 36-week data from the Phase 3 BRAVE-AA-PEDS study evaluating the safety and efficacy of once-daily, oral Olumiant compared with placebo in the cohort of patients ages 12 to under 18. Treatment with Olumiant helped many adolescents achieve near-complete scalp hair regrowth. Additionally, many patients achieved successful eyebrow and eyelash regrowth.

“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, M.D., PhD, 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.”

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Related Topics and Keywords

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