Regeneron Pharmaceuticals and Sanofi said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending EU approval of Dupixent (dupilumab) to treat moderate-to-severe chronic spontaneous urticaria in children aged 2 to 11 years whose symptoms are not adequately controlled by H1 antihistamines and who are naïve to anti-IgE therapy. The companies said a final EU decision is expected in the coming months, and that the U.S. FDA has accepted a supplemental Biologics License Application for review for the same age group, with a decision expected by April 2026.

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