Dupilumab Gains Pediatric CSU Approval
Targets type 2 inflammation in a population with limited treatment options
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By
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Kathryn Wighton
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April 24, 2026
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Dupixent (dupilumab) is now approved for pediatric patients aged 2 to 11 years with chronic spontaneous urticaria (CSU) in the US.
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The approval is based on the Phase 3 LIBERTY-CUPID clinical program, demonstrating efficacy in reducing itch severity and urticaria activity.
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Dupilumab showed higher rates of well-controlled disease and complete response compared to standard antihistamine therapy.
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Injection site reactions were the most common adverse events, but no new safety concerns were identified in the pediatric population.
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Dupilumab is the first biologic therapy approved in the US for young children with uncontrolled CSU, expanding treatment options.