The European Commission has approved Dupixent (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria in children aged 2 to 11 years who have not responded adequately to antihistamines and are naive to anti-IgE therapy. The approval makes Dupixent the first targeted medicine in the EU indicated for young children with this condition.
The decision builds on data from the LIBERTY-CUPID clinical program, including adult Phase 3 studies and the CUPIDKids pediatric Phase 3 study. Dupixent significantly reduced urticaria activity compared with placebo at week 24, demonstrating efficacy in reducing itch and hive severity. Safety data in children aged 2 to 11 proved consistent with adult safety profiles, with the most common adverse reactions including injection site reactions, conjunctivitis, arthralgia, and oral herpes.
Developed by Sanofi and Regeneron, Dupixent inhibits IL-4 and IL-13 signaling pathways that drive the type 2 inflammation underlying chronic spontaneous urticaria. The EU approval follows the positive CHMP opinion issued in February 2026.