Regeneron Pharmaceuticals and Sanofi have announced that the European Commission has approved Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years weighing at least 15 kg. This makes Dupixent the first and only medication approved for this young population in the European Union, with prior approvals for EoE treatment in adults and adolescents. The decision follows robust results from the EoE KIDS Phase 3 trial, demonstrating significant improvements in histological disease remission, esophageal eosinophil count reduction, and disease severity alleviation. The trial also confirmed that Dupixent’s safety profile in children aligns with its established safety in older populations.
EoE is a chronic, progressive disease linked to type 2 inflammation, significantly affecting children’s ability to eat and thrive. The approval of Dupixent addresses a critical need, as up to half of children in the EU remain uncontrolled despite standard treatments. With its proven efficacy and safety, Dupixent offers a targeted therapy that can alleviate disease symptoms and improve nutritional outcomes for children. Administered as a subcutaneous injection, Dupixent can be given at home or in a clinical setting, providing a flexible treatment option under professional guidance.
