Regeneron And Sanofi Say European Medicines Agency's CHMP Adopts Positive Opinion Recommending Approval Of Dupixent In EU For Treatment Of Chronic Spontaneous Urticaria

If approved, Dupixent would be the first targeted medicine in the EU indicated for children aged 2 to 11 years with CSU inadequately controlled by standard-of-care antihistamine treatment

CSU is a chronic skin disease with underlying type 2 inflammation that can cause debilitating hives and recurring itch in young children

TARRYTOWN, N.Y. and PARIS, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU). This recommendation covers children aged 2 to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. A final decision is expected in the coming months.

The positive CHMP opinion in young children is supported by data from the LIBERTY-CUPID clinical trial program, including two Phase 3 trials, Study A and Study C, in which children aged 6 to 11 years participated, and the single-arm, CUPIDKids Phase 3 trial in children aged 2 to 11 years with CSU.

Dupixent is approved for CSU in certain adults and adolescents in several jurisdictions, including the United States (U.S.), the EU and Japan.

In the U.S., a supplemental Biologics License Application (sBLA) has been accepted for review seeking approval for Dupixent in certain children aged 2 to 11 years with CSU. The U.S. Food and Drug Administration (FDA) decision is expected by April 2026.

The safety and efficacy of Dupixent for CSU in adults and adolescents have not been fully evaluated outside of jurisdictions where it has been approved. The safety and efficacy of Dupixent for CSU in children aged 2 to 11 years have not been fully evaluated by any regulatory authority.