Dupixent Approved in EU for Pediatric Chronic Spontaneous Urticaria

The European Commission has approved Dupixent (dupilumab), developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in children aged two to 11 years. The authorization establishes Dupixent as the first targeted medicine approved in the European Union for this pediatric population.

The approval applies to children with moderate-to-severe CSU who have shown an inadequate response to histamine-1 antihistamines (H1AH) and are naive to anti-immunoglobulin E (IgE) therapy for the condition.

Clinical Trial Foundation

The regulatory decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued on February 27, 2026. The recommendation was based on data from the LIBERTY-CUPID clinical study program.

This program included two phase 3 studies, designated as Study A and Study C, which involved children aged six to 11 years. The program included the single-arm, CUPIDKids phase 3 study, which focused on children aged two to 11 years with CSU.

Expansion of EU Indications

The pediatric approval expands the existing EU indication for Dupixent in CSU. On November 25, 2025, the European Commission approved the medicine for the treatment of moderate-to-severe CSU in adult and adolescent patients aged 12 years and older who had an inadequate response to H1AH and were naive to anti-IgE therapy.

At the time of the November 25, 2025, approval, data indicated that approximately 270,000 adults and adolescents aged 12 and older in the EU lived with CSU and remained symptomatic despite standard-of-care antihistamine treatment.

With the addition of the pediatric indication, Dupixent is now approved for patients across seven chronic, inflammatory diseases within the European Union.

Mechanism and Disease Impact

CSU is a chronic skin disease characterized by underlying type 2 inflammation, which results in recurring itch and debilitating hives. Dupixent treats the condition by inhibiting IL4 and IL13, which are two central drivers of type 2 inflammation.

In phase 3 studies for the adult and adolescent population, Dupixent was shown to significantly reduce hives and itch at 24 weeks when compared to a placebo.

United States Regulatory Status

Sanofi and Regeneron are seeking similar approval for the pediatric population in the United States. A supplemental biologics license application has been accepted for review by the U.S. Food and Drug Administration (FDA) for the use of Dupixent in certain children aged two to 11 years with CSU.

The FDA decision regarding this application is expected by April 2026.