TARRYTOWN, N.Y. and PARIS, April 13, 2026
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved Dupixent® (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years, marking a groundbreaking milestone as the first targeted therapy for this young population in the EU. This approval significantly expands the drug’s indication, reinforcing its position as a leading biologic therapy addressing type 2 inflammatory diseases and providing new hope for pediatric patients with limited treatment options.
First Targeted Therapy for Pediatric CSU in EU
The approval represents a major advancement in pediatric dermatology and immunology, as Dupixent becomes the first and only targeted medicine approved for young children with CSU in Europe. Chronic spontaneous urticaria is a debilitating inflammatory skin disease characterized by persistent hives and intense itching, often severely impacting quality of life during critical developmental years.
The decision applies to children who remain symptomatic despite standard treatment with histamine-1 antihistamines (H1AH) and who have not received anti-IgE therapies. This expansion builds upon previous approvals for adolescents and adults, further strengthening Dupixent’s role across multiple type 2 inflammation-driven diseases. With this approval, Dupixent is now authorized for children under 12 across four chronic conditions, showcasing its broad therapeutic versatility and strong safety profile.
Strong Clinical Evidence from LIBERTY-CUPID Program
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The European Commission’s decision is supported by robust data from the LIBERTY-CUPID Phase 3 clinical trial program, including pivotal studies demonstrating significant reductions in urticaria activity, itch severity, and hive formation compared to placebo.
The trials showed that patients treated with Dupixent experienced improved disease control and higher rates of complete response at 24 weeks, highlighting its clinical efficacy. Importantly, the pediatric data were reinforced through pharmacokinetic, safety, and efficacy findings from the CUPIDKids trial, confirming consistency with adult outcomes.
The therapy demonstrated a well-established safety profile, with commonly reported adverse events including injection site reactions and mild inflammatory responses, aligning with previously approved dermatological indications. These findings underscore Dupixent’s ability to target the underlying drivers of disease rather than merely alleviating symptoms.
Mechanism Targets Core Drivers of Inflammation
Dupixent is a fully human monoclonal antibody designed to inhibit interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key drivers of type 2 inflammation implicated in CSU and other chronic conditions. By targeting these pathways, Dupixent offers a precision medicine approach that directly addresses the disease mechanism.
Unlike traditional immunosuppressants, Dupixent is not broadly immunosuppressive, reducing potential systemic risks while maintaining efficacy. Administered as a subcutaneous injection, the therapy can be delivered in clinical settings or at home under caregiver supervision, enhancing treatment accessibility and convenience for pediatric patients.
Globally, Dupixent has already been approved in more than 60 countries across multiple indications and is used by over 1.4 million patients, demonstrating its widespread clinical acceptance and real-world impact.
This latest EU approval underscores the continued commitment of Regeneron and Sanofi to expanding innovative biologic therapies into underserved patient populations, particularly young children facing chronic and life-disrupting diseases. With regulatory reviews also ongoing in other regions, including the United States, Dupixent is poised to further strengthen its position as a cornerstone therapy in immunology and inflammatory disease management.
Source: Regeneron, Sanofi press release
