CHMP Recommendation
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for treating adolescents aged 12 to under 18 with severe alopecia areata (AA). This recommendation is based on data from the Phase 3 BRAVE-AA-PEDS study.
Study Results
The BRAVE-AA-PEDS study, the first and largest of its kind for this age group, showed that 42% of patients with severe AA achieved 80% or more scalp hair coverage at 36 weeks. This study specifically targeted children and adolescents, addressing a significant gap in treatment options for this demographic.
Regulatory Process
Following the CHMP's positive opinion, the decision now moves to the European Commission, with a final decision expected within the next one to two months. If approved, Olumiant will expand its use to include adolescents, having already been approved for adults with severe AA in both the European Union and the United States.
Olumiant Overview
Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Eli Lilly. It was the first JAK inhibitor approved for severe AA in adults in 2022, marking a significant advancement in treatment options for this chronic immune disease.
