French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) announced on Monday that they have received European Commission approval for Dupixent (dupilumab) to treat moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years who remain uncontrolled on standard antihistamines.

This decision extends the therapy's indication beyond patients aged 12 and older, making it the first targeted medicine in the EU to treat young children with CSU.

The approval is supported by data from the LIBERTY-CUPID clinical programme, including phase 3 studies demonstrating significant reductions in urticaria activity, itch severity, and hive presentation compared with placebo in adults. These findings were complemented by pharmacokinetic, safety, and efficacy data from the CUPIDKids trial in younger patients.

Dupixent showed improved disease control and higher rates of complete response at 24 weeks, with safety outcomes consistent with its established profile across dermatological indications.

The latest approval expands Dupixent's EU paediatric use to children under 12 across four chronic diseases linked to type 2 inflammation. In parallel, a supplemental BLA for the therapy in the same paediatric CSU population is under review in the United States, while broader clinical development continues across multiple inflammatory conditions.