WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi on Thursday announced that the FDA has approved Dupixent (dupilumab) for treating pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
The FDA approval is based on data from the Phase 3 EoE KIDS trial evaluating the efficacy and safety of Dupixent in children aged 1 to 11 years with EoE.
This 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 associated with type 2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function.
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