Press release
Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria (CSU) Advances in EU with Positive CHMP Opinion
Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the European Union (EU) TARRYTOWN, N.Y. and PARIS, Sept. 22, 2025 (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) has adopted a positive opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those aged 12 years and above with moderate-to-severe disease, with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti-immunoglobulin E (IgE) therapy. A final decision is expected in the coming months. The positive CHMP opinion is supported by data from two trials in the LIBERTY-CUPID Phase 3 program (Study A and Study C), both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third trial from the LIBERTY-CUPID program (Study B), conducted in a different CSU patient population, provided additional safety data. The safety results of the trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events (AEs) more commonly observed with Dupixent (≥5%) than placebo in the trials of adults and adolescents with CSU were injection site reaction, COVID-19, hypertension, CSU and accidental overdose. Dupixent is approved for CSU in certain adults and adolescents in several countries including Japan and the United States. Outside of approved jurisdictions, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority. About CSUCSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals conti...