04:12 AM EDT, 09/22/2025 (MT Newswires) -- Sanofi ( SNY ) and Regeneron Pharmaceuticals ( REGN ) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of Dupixent in the European Union for the treatment of chronic spontaneous urticaria in adults and adolescents.

The recommendation covers patients aged 12 years and above with moderate-to-severe disease who have had an inadequate response to antihistamines and who are new to anti-immunoglobulin E therapy, the companies said.

The companies said a final decision on the drug is expected in the coming months.

The positive opinion was supported by data from two trials that showed Dupixent reduced itch and hives at 24 weeks compared to placebo, the companies said.