Dupixent (dupilumab) to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion

Regeneron Pharmaceuticals

22 September 2025 - Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo.

Regeneron Pharmaceuticals and Sanofi today announced that the EMA’s CHMP has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents.

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder