Regeneron : Positive Dupixent Phase 3 Results In Eosinophilic Esophagitis Published

(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that 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.

eosinophilic esophagitis is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The data formed the basis for the U.S. Food and Drug Administration approval of Dupixent in May 2022, making it the first and only medicine indicated to treat patients with eosinophilic esophagitis aged 12 years and older, weighing at least 40 kg, Regeneron said.

The company noted that the phase 3 data have been submitted to the European Medicines Agency (EMA) to support regulatory approval for adults and adolescents with eosinophilic esophagitis. 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.

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events (=5%) that were more commonly observed with Dupixent included injection site reactions, nasopharyngitis and rash.

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