Sanofi and Regeneron’s Dupixent Recommended for EU Approval in Treating Pediatric CSU

Sanofi and Regeneron have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in children aged two to 11. If approved, Dupixent would be the first targeted medicine in the EU for children with CSU inadequately managed by antihistamines. This condition is known for causing debilitating hives and itching due to type 2 inflammation, affecting children's quality of life.

The recommendation is based on the LIBERTY-CUPID clinical program, which included studies with participants aged six to 11 years, and a study focusing on those aged two to 11 years. Dupixent is already approved for CSU in adults and adolescents in the US, EU, and Japan. A decision from the European Commission is pending, and the US FDA is expected to decide by April 2026. Both Sanofi and Regeneron continue to explore Dupixent's potential in other inflammatory diseases.