Dupixent (dupilumab) approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria

Regeneron Pharmaceuticals

22 April 2026 - Approval for children aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite H1 anti-histamine treatment based primarily on data from the LIBERTY-CUPID clinical trial program.

Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite histamine 1 anti-histamine treatment.

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder