Sanofi’s Dupixent Wins Approval in Pediatric EoE

The U.S. FDA has approved Sanofi’s Dupixent (dupilumab) for the treatment of pediatric patients aged 1 to 11 years with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. 

This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
 
EoE is a chronic, progressive disease driven in part by type 2 inflammation that damages the esophagus and impairs its function. EoE can severely impact a child’s ability to eat, and they may experience heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive. Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies. 
 
Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation at Sanofi, said, “Young children with eosinophilic esophagitis have significant unmet medical needs; despite existing treatment options, 40% of these children in the U.S. under the age of 12 continue to experience symptoms of this disease. Today’s approval underscores our commitment to bringing therapies to young patients with unmet needs and also brings hope to these patients who are at a critical age where struggling to eat and maintain weight directly impacts their overall nutritional intake and development.”