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Dupixent approved in US as first biologic for young children with uncontrolled chronic spontaneous urticaria

Market News
22 Apr 2026
Sanofi And Regeneron
View Source
Bullish
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The FDA has approved Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in children aged 2 to 11 who remain symptomatic despite antihistamine treatment. This approval expands existing indications for older patients and is based on clinical trial data showing significant symptom reduction. Dupixent targets key inflammatory pathways, offering a new option for young children with limited alternatives. The drug is already approved for CSU in children in the EU and other countries, with ongoing studies for additional inflammatory conditions.

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