Dupixent recommended for approval to treat chronic spontaneous urticaria in children with ongoing symptoms

Sanofi has announced that the EMA’s Committee for Medicinal Products for Human Use has recently adopted a positive opinion recommending the approval of Dupixent in the EU for the treatment of chronic spontaneous urticaria. This recommendation covers children aged two to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines, and who are naïve to anti-immunoglobulin E therapy for CSU.

Note that Dupixent is approved for CSU in certain adults and adolescents in several jurisdictions including the US, the EU, and Japan.

In the US, a supplemental biologics license application has been accepted for review seeking approval for Dupixent in certain children aged two to 11 years with CSU. The US FDA decision is expected by April 2026.

In addition, the safety and efficacy of Dupixent for CSU in adults and adolescents have not been fully evaluated outside of jurisdictions where it has been approved. The safety and efficacy of Dupixent for CSU in children aged two to 11 years have not been fully evaluated by any regulatory authority.

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Related Topics and Keywords

chronic spontaneous urticaria, Dupixent