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EU approves Dupixent as first targeted treatment for chronic spontaneous urticaria in children aged 2-11

Market News
13 Apr 2026
Sanofi/Regeneron
View Source
Bullish
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The European Commission has approved Dupixent (dupilumab) for treating moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 who do not respond adequately to antihistamines and have not previously received anti-IgE treatment. This expands Dupixent's indication in the EU from adults and adolescents to younger children, offering a new targeted therapy option for a condition that causes sudden, debilitating hives and itching. The approval is based on clinical trial data showing significant reduction in urticaria activity and a favorable safety profile. Dupixent is now approved for four chronic inflammatory diseases in children under 12 in the EU, with ongoing studies and regulatory reviews in other regions including the US.

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