European Commission Approves Dupixent For Young Children With Chronic Spontaneous Urticaria, Expanding EU Use

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 who do not respond adequately to histamine-1 antihistamines and have not previously received anti-IgE therapy. This decision expands the previous European approval, which covered adults and adolescents aged 12 and older with CSU. The condition is a chronic inflammatory skin disease that leads to sudden, persistent hives and intense itching.

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, said that young children with CSU often face constant itching and visible hives during key years of growth. He explained that Dupixent is now the first targeted treatment available in the EU for this age group, offering a potential new standard of care for children who continue to experience symptoms despite other existing therapies. He also noted that Dupixent is the most widely used branded antibody medicine globally, and this approval extends its demonstrated efficacy and long-term safety to another vulnerable group.

The European approval is supported by results from the LIBERTY-CUPID clinical trial program. This includes data extrapolated from two Phase 3 trials in adults (Study A and Study C), along with pharmacokinetic, safety and efficacy findings from the CUPIDKids Phase 3 trial involving children aged 2 to 11 with CSU. In adults, Study A and Study C showed that Dupixent significantly reduced overall urticaria activity — which measures itch and hives — and also improved individual scores for itch and hive severity at week 24 compared with placebo. More patients receiving Dupixent also achieved well-controlled disease and complete response at week 24.

Safety findings from Study A, Study C and CUPIDKids were generally in line with the known safety profile of Dupixent for its approved dermatology uses. The most common side effects seen across indications include injection site reactions, conjunctivitis (and allergic conjunctivitis), joint pain, oral herpes and eosinophilia. In the CSU adult and adolescent trials, additional reactions such as injection site induration, dermatitis and bruising or hematoma were also observed. In adults and adolescents with CSU, COVID-19 was the only adverse event reported more often with Dupixent than with placebo (≥5%). Safety data in children aged 2 to 11 years were consistent with what has been seen in older patients treated with Dupixent for CSU.

Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head for Immunology Development at Sanofi, noted that earlier treatment options for young children with CSU often left patients with persistent, uncontrolled symptoms. She explained that Dupixent blocks the signaling of IL-4 and IL-13, two key drivers of type 2 inflammation, offering a new and targeted way to manage the disease. She added that this approval reflects the companies’ commitment to expanding the benefits of Dupixent to all patients who may need it, including younger children.

In the United States, a supplemental Biologics License Application for Dupixent in certain children aged 2 to 11 with CSU is currently under review. The medicine is already approved for CSU in specific adult and adolescent populations in several regions, including the U.S. and Japan.

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