Dupixent® (dupilumab) Approved in the EU as the First Targeted Medicine to Treat Young Children with Chronic Spontaneous Urticaria (CSU)
Regeneron Pharmaceuticals, Inc. (REGN)
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Source: GlobeNewswire
Approval in CSU for children 2 to 11 years of age is based on data from the LIBERTY-CUPID clinical trial program, including an extrapolation of efficacy data showing that Dupixent significantly reduced urticaria activity compared with placebo in adults The latest approval expands Dupixent’s indication for CSU in the EU to children as young as 2 years; Dupixent is now approved for children less than 12 years of age across four chronic diseases driven in part by type 2 inflammation TARRYTOWN, N.Y. and PARIS, April 13, 2026 (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 children aged 2 to 11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. This expands the previous approval in the EU for adults and adolescen
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- 1/30/26 - Beat
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- 4/8/26 - Form 8-K
- 4/3/26 - Form 4
- 3/27/26 - Form SCHEDULE
- REGN's page on the SEC website