Global Finance News
13 Apr 2026, 15:02
Sanofi and Regeneron Pharmaceuticals announced that the European Commission has approved Dupixent (dupilumab) for treating children aged 2 to 11 with chronic spontaneous urticaria (CSU), marking the first targeted therapy for this age group in the EU.
The approval expands Dupixent’s indication beyond adults and adolescents, offering a new option for young patients whose condition remains uncontrolled with standard antihistamine treatments. CSU is a chronic inflammatory skin disease characterized by severe itching and recurrent hives, significantly affecting quality of life.
The decision is based on results from the LIBERTY-CUPID clinical program, which showed that Dupixent significantly reduced disease activity compared with placebo and improved symptom control. Safety outcomes were consistent with the drug’s established profile across other indications.
With this latest authorization, Dupixent is now approved in the EU for children under 12 across multiple diseases linked to type 2 inflammation, further strengthening its position as a leading biologic therapy in immunology.
The approval expands Dupixent’s indication beyond adults and adolescents, offering a new option for young patients whose condition remains uncontrolled with standard antihistamine treatments. CSU is a chronic inflammatory skin disease characterized by severe itching and recurrent hives, significantly affecting quality of life.
The decision is based on results from the LIBERTY-CUPID clinical program, which showed that Dupixent significantly reduced disease activity compared with placebo and improved symptom control. Safety outcomes were consistent with the drug’s established profile across other indications.
With this latest authorization, Dupixent is now approved in the EU for children under 12 across multiple diseases linked to type 2 inflammation, further strengthening its position as a leading biologic therapy in immunology.
