FDA accepts supplemental biologics license application for Dupixent for EoE

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