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.