Dupixent from Sanofi and Regeneron approved for young children in the EU

The European Commission has approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in children aged two to 11 years. This decision is based on data from the LIBERTY-CUPID clinical trial program, confirming the drug's efficacy in children, which has already been demonstrated in adults. Dupixent, which targets type 2 inflammation, thus becomes the first drug specifically for young children suffering from CSU.

Alyssa Johnsen of Sanofi emphasizes that this approval represents a major advancement in treating children unable to control their condition with previous treatments. Studies have demonstrated a significant reduction in urticaria symptoms compared to placebo.

Although the drug's safety profile is generally consistent, some side effects have been reported, including injection site reactions and conjunctivitis. In the United States, an application is pending to expand this authorization.