CHMP adopted a positive opinion by consensus for an extension of indication for Olumiant to include the treatment of adolescent patients aged 12 to less than 18 years with severe alopecia areata. (European Medicines Agency) - Aug 30, 2026 - CHMP Final
Minutes of the meeting on 23 - 26 Feb 2026: The extension is supported
by results from the Phase 3, randomized, double-blind, placebo-controlled I4V-MC-JAIO
study evaluating the efficacy, safety and pharmacokinetics of baricitinib in
children and adolescents with alopecia areata. Consequently, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of
the SmPC were updated, with the CHMP Assessment Report and
translation timetable also adopted. [AI generated summary]
CHMP • Alopecia • Immunology
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