FDA expands Dupixent approval to children aged 2–11 with chronic spontaneous urticaria, marking the first biologic option for this population and extending its reach across type 2 inflammatory diseases.
FDA expanded its approval of Dupixent (dupilumab) to include children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine-1 antihistamines.
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The approval marks the first biologic therapy available in the U.S. for this younger patient population and broadens the drug’s existing indication, which
Dupixent works by blocking interleukin-4 and interleukin-13 signaling, key drivers of type 2 inflammation, positioning it as a targeted option for diseases with underlying immune dysregulation.1 The latest approval reinforces the drug’s expanding role as a platform therapy across multiple allergic and inflammatory conditions.
FDA’s expanded approval of the treatment also addresses a persistent treatment gap in pediatric CSU, a condition characterized by recurrent hives and severe itching that can significantly impact quality of life.1
While antihistamines remain the standard of care, a subset of patients continues to experience uncontrolled symptoms, highlighting the need for targeted therapies.
“With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” said George D. Yancopoulos, M.D., Ph.D., board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent. “Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children.”
The expanded approval decision is supported by data from the Liberty-Cupid clinical trial program, including two Phase III placebo-controlled studies in adults and adolescents, alongside pharmacokinetic data from the CupidKids trial in children aged 2 to 11 years.
Across the studies, Dupixent demonstrated significant reductions in itch severity and overall disease activity compared to placebo at 24 weeks, while also improving the likelihood of achieving well-controlled disease or complete response in older populations.2
Safety findings remained consistent with the therapy’s established profile across dermatologic indications, with the most commonly reported adverse events being injection site reactions.2 No new safety signals were identified in the pediatric population.
“Children with uncontrolled chronic spontaneous urticaria continue to experience the unpredictable appearance of debilitating itch and hives,” said Alyssa Johnsen, M.D., Ph.D., global therapeutic area head, Immunology Development at Sanofi. “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of chronic spontaneous urticaria. Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling.”
From a market perspective, the label expansion further strengthens Dupixent’s position as a leading biologic franchise, with approvals now spanning nine indications.
Beyond the U.S., Dupixent is already approved for CSU in certain pediatric populations in the European Union and other markets, suggesting continued global expansion in this indication.
