Press release
Dupixent® (dupilumab) Approved as the First Targeted Medicine in the European Union (EU) in Over a Decade for Chronic Spontaneous Urticaria (CSU)
Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo In the EU, there are approximately
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo In the EU, there are approximately 270,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite standard-of-care antihistamine treatment Dupixent, which inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation, is now approved for patients across seven chronic, inflammatory diseases in the EU TARRYTOWN, N.Y. and PARIS, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. Eligible patients can use Dupixent as a first-line targeted treatment option. “The unpredictable nature of chronic spontaneous urticaria leaves patients guessing when they’ll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging,” said Tonya Winders, President & CEO, Global Allergy & Airways Patient Platform. “Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.” “The approval of Dupixent for certain adults and adolescents with chronic spontaneous urticaria in the European Union represents the first innovation for patients with this disease in over a decade,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL-4 and IL-13, two key drivers of type 2 inflammation, and can offer patients significant improvement in debilitating itch and hives. This approval further demonstrates the ability of Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.” The approval is based on data from two Phase 3 clinical trials in the LIBERTY-CUPID program. Study A and Study C included 284 patients aged 12...