FDA Approves Dupixent for Children Aged 1-11 with Eosinophilic Esophagitis

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, who have eosinophilic esophagitis (EoE). This approval establishes Dupixent as the first and only medicine approved in the U.S. specifically indicated for this younger age group.

Eosinophilic esophagitis is a chronic disease characterized by type 2 inflammation that can damage the esophagus, leading to symptoms such as difficulty eating, heartburn, and vomiting. Sanofi reports that approximately 21,000 children under 12 in the U.S. are currently treated for EoE with unapproved therapies.

The expanded FDA approval is based on data from the Phase 3 EoE KIDS trial. The trial demonstrated that a significantly higher proportion of children treated with Dupixent achieved histological disease remission compared to those receiving a placebo. Specifically, 66% of children treated with Dupixent achieved histological remission at 16 weeks, versus 3% in the placebo group.

This approval for younger pediatric patients with EoE underscores Sanofi's commitment to providing treatments for children with significant unmet medical needs. This is the second disease Indicating Type 2 inflammation for which Dupixent is approved in children under 12 in the U.S.