RegulatoryApr 22, 2026, 05:31 PM
FDA Approves Dupixent for Children Aged 2-11 with Chronic Urticaria
AI Summary
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has approved Dupixent (dupilumab) for treating children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. This approval makes Dupixent the first biologic medicine in the U.S. for this young patient population, expanding its previous approval for adults and adolescents with CSU. The decision is primarily based on data from the LIBERTY-CUPID clinical trial program, reinforcing Dupixent's established safety profile and potential to transform outcomes for type 2 inflammation-driven chronic diseases.
Key Highlights
- FDA approved Dupixent for children aged 2 to 11 years with chronic spontaneous urticaria (CSU).
- This expands Dupixent's approval for CSU from adults and adolescents (12+ years).
- Dupixent is the first biologic medicine in the U.S. for young children with uncontrolled CSU.
- Approval based on LIBERTY-CUPID clinical trial program data.
- Dupixent is now approved for nine allergy-related conditions, with five extended to young children.