18 April 2025 - Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo.
Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite histamine- antihistamine treatment.