Press Release: Sanofi and Regeneron’s Dupixent approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria
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The European Union has approved Dupixent, a medicine developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria in children aged 2-11. This approval expands Dupixent's indication for CSU in the EU to children as young as two years, providing a new treatment option for young children with this condition.
Sanofi and Regeneron's Dupixent has been approved in the EU for the treatment of chronic spontaneous urticaria in children aged 2-11. The approval is based on data from the LIBERTY-CUPID clinical study program, which showed that Dupixent significantly reduced urticaria activity compared to placebo in adults. The medicine is now approved for children less than 12 years old across four chronic diseases driven by type 2 inflammation. Dupixent is the first targeted medicine to treat young children with CSU in the EU. The approval is a significant development for young children suffering from this condition, who often experience unrelenting itch and visible hives. The safety profile of Dupixent in children was consistent with its known safety profile in adults.
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