Health
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 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,
About this update from Sanofi Sa
[{"type":"image","alt":"Regeneron Pharmaceuticals, Inc.","displaySize":"","headline":null,"caption":"Regeneron Pharmaceuticals, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":47,"url":"https://media.zenfs.com/en/globenewswire.com/dd48a84a10e2c569a1750589118f2d19"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/OMbrbjdR7YYzdW3N_PREZQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTY2O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/dd48a84a10e2c569a1750589118f2d19","width":300,"height":47}},"lazy":false},{"type":"text","content":"Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo","length":118,"tagName":"p"},{"type":"text","content":"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","length":177,"tagName":"p"},{"type":"text","content":"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","length":175,"tagName":"p"},{"type":"text","content":"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.","length":537,"tagName":"p"},{"type":"text","content":"“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.”","length":435,"tagName":"p"},{"type":"text","content":"“The approval of Dupixent for certain adults and adolescents with chronic spontaneous urticaria ...