Sanofi and Regeneron’s Dupixent Gains EU Approval for Treating Young Children with CSU

The European Commission has granted approval for Dupixent (dupilumab) to treat children aged two to 11 with chronic spontaneous urticaria (CSU) who have not responded to antihistamines. This expands the prior endorsement, which covered individuals 12 years and older. The approval stems from the LIBERTY-CUPID clinical study, highlighting Dupixent's effectiveness in reducing urticaria activity compared to placebo.

Alyssa Johnsen, MD, PhD, noted Dupixent's role as the first targeted medicine addressing young children's CSU. The clinical trials indicate Dupixent significantly lessens urticaria activity and improves disease control. Safety profiles were consistent with earlier findings, featuring common adverse reactions like injection site reactions and conjunctivitis.

This represents Dupixent's fourth approval for children with chronic diseases driven by type 2 inflammation. Its further potential impact is under evaluation in the US for similar age groups.