Regeneron Pharmaceuticals, Inc. and Sanofi announced on April 20, 2026, that the European Commission has expanded the marketing authorization for Dupixent (dupilumab) in the European Union. The drug is now approved as an add-on therapy for children aged 2 to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. This regulatory milestone establishes Dupixent as the first and only biologic medicine approved in the European Union to treat this specific pediatric patient population, addressing a group that previously had limited therapeutic options beyond standard antihistamines.
The European Commission’s decision was supported by data from the LIBERTY-CUPID Phase 3 clinical trial program, which evaluated the efficacy and safety of Dupixent in pediatric patients with uncontrolled CSU. In these trials, patients receiving Dupixent as an add-on to standard-of-care antihistamines experienced a significant reduction in itch severity and hive count compared to those on antihistamines alone. Specifically, the clinical data demonstrated that a substantially higher proportion of children achieved clear or almost clear skin when treated with the biologic. The safety profile observed in the pediatric CSU population was generally consistent with the established safety profile of Dupixent in its other approved dermatological and respiratory indications, with common side effects including injection site reactions and infections.
George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President, and Chief Scientific Officer at Regeneron, stated that the approval addresses a significant unmet need for young children suffering from the debilitating and often unpredictable effects of chronic hives. He noted that the expansion into the 2-to-11-year-old demographic reinforces the role of IL-4 and IL-13 signaling in the pathogenesis of CSU. Sanofi executives highlighted that this approval further solidifies Dupixent’s position as a foundational therapy for type 2 inflammatory diseases. The companies confirmed that the European Commission's decision applies to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. It is not an immunosuppressant. With this latest approval, Dupixent now holds indications in the EU for several conditions across different age groups, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. In the previous fiscal year, Dupixent continued to be a primary revenue driver for both Regeneron and Sanofi, with global net sales exceeding 13 billion euros. The companies are currently investigating dupilumab in other diseases driven by type 2 inflammation, including chronic obstructive pulmonary disease and various allergic conditions.