Posted by Michael Wonder on 25 Nov 2025
Dupixent (dupilumab) approved as the first targeted medicine in the European Union in over a decade for chronic spontaneous urticaria
25 November 2025 - Approval 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 European Commission has approved Dupixent (dupilumab) for the treatment of moderate to severe chronic spontaneous urticaria in adult and adolescent patients 12 years and above with inadequate response to histamine 1 anti-histamines and who are naïve to anti-immunoglobulin E therapy for chronic spontaneous urticaria.
