
Regeneron and Sanofi Announce FDA Approval of Dupixent for Eosinophilic Esophagitis in Children
Regeneron and Sanofi receive FDA approval for Dupixent (dupilumab) for eosinophilic esophagitis in children aged 1-11 years, expanding treatment options for this rare condition.
Regeneron and Sanofi today announced that the FDA has approved Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 years weighing at least 15 kg. This approval makes Dupixent the first biologic approved for EoE in this age group. EoE is a chronic, allergic inflammatory disease of the esophagus that can cause difficulty swallowing, food impaction, and failure to thrive in children. In the Phase 3 EoE KIDS trial, Dupixent demonstrated significant improvements in histologic response and symptom scores compared to placebo. This approval expands Dupixent's use in pediatric patients with type 2 inflammatory diseases.
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Business Wire