FDA accepts supplemental biologics license application for Dupixent for EoE

Regeneron Pharmaceuticals Inc. and Sanofi announced that the FDA accepted for priority review a supplemental biologics license application for Dupixent 300 mg for adults and children aged 12 years and older with eosinophilic esophagitis.According to a release from the biotechnology companies, the application was supported by two phase 3 trials that assessed the efficacy and safety of 300 mg weekly Dupixent (dupilumab; Sanofi Genzyme, Regeneron) in patients aged 12 years and older with EoE, as well as data from an active long-term extension trial.Compared with placebo, dupilumab at 24 weeksRead More