The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending Dupixent (dupilumab) for treating chronic spontaneous urticaria in children aged 2 to 11 years who have not responded adequately to standard antihistamine treatment. If approved, Dupixent would become the first targeted medicine in the EU indicated for this young patient population.
The recommendation is supported by the LIBERTY-CUPID clinical study program, including the CUPIDKids Phase 3 study. Dupixent is a monoclonal antibody developed by Sanofi and Regeneron that inhibits IL-4 and IL-13 signaling pathways targeting type 2 inflammation.
A final European Commission decision and U.S. FDA review are both anticipated for April 2026. The positive CHMP opinion reflects growing momentum for extending Dupixent’s use into younger patient populations across multiple inflammatory conditions.