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, 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, weighing at least 40 kg.
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, additional to inducing heartburn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive, which can impact their overall growth and development.
Continuous treatment of EoE may be needed to reduce the risk of complications and disease progression.
Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies. However, the actual prevalence of children with the disease is likely higher, given symptoms can be mistaken for other conditions and there are delays in diagnosis.
Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi comments: “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.”
