04:12 AM EST, 11/25/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Tuesday the European Commission has authorized Dupixent, or dupilumab, for certain adults and adolescents aged 12 years and above with moderate-to-severe chronic spontaneous urticaria.

The approval covers patients with inadequate response to histamine-1 antihistamines and who are naive to anti- immunoglobulin-E therapy for CSU, an inflammatory skin disease.

The drugmakers said the approval is backed by two phase 3 trials showing that, when added to standard antihistamines, Dupixent significantly reduced overall urticaria activity as well as itch and hive severity at 24 weeks, compared with placebo, and increased rates of well-controlled disease and complete response.