Sanofi and Regeneron Pharmaceuticals Inc. announced on Thursday that the FDA has approved their drug, Dupixent (dupilumab), for treating children aged between 1 to 11 years who weigh at least 15 kg, and have eosinophilic esophagitis (EoE).
The FDA based its approval on the findings from a Phase 3 EoE KIDS trial. This trial assessed the drug's effectiveness and safety in toddlers and children within that age bracket who were suffering from EoE.
This approval builds on an original FDA approval granted in May 2022, which was for treating EoE in individuals aged 12 years and above, who weighed at least 40 kg. The FDA assessed Dupixent under its Priority Review scheme. This scheme is intended for medicines that can offer substantial improvements in the effectiveness or safety of treatments for severe conditions.
EoE, a progressive and chronic ailment, is linked to type 2 inflammation. It is believed that this inflammation can damage the esophagus, affecting its functionality.
