Regeneron’s Dupixent shows disease remission in Phase 3 esophagitis trial

Regeneron (REGN) and Sanofi (SNY) announced the New England Journal of Medicine has published results from a positive Phase 3 trial showing adults and adolescents treated with Dupixent – dupilumab – 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis – EoE -, which were sustained for up to one year. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. These data formed the basis for the FDA approval of Dupixent in May 2022. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. These Phase 3 data have been submitted to the EMA to support regulatory approval for adults and adolescents with EoE. The EMA’s Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval, with a final decision expected in the coming months. Patients receiving Dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. Additionally, these patients experienced improved anatomic, cellular, molecular and health-related quality of life measures sustained for up to one year. Patients treated with Dupixent every two weeks experienced histological disease remission but did not experience improvement in the ability to swallow. Safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent included injection site reactions, nasopharyngitis and rash.