Regeneron, Sanofi announce results from Phase 3 trial evaluating Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that results from a Phase 3 trial evaluating the investigational use of Dupixent showed consistent efficacy and safety for up to one year in children aged 1 to 11 years with eosinophilic esophagitis. These results represent the first analysis of longer-term data in this age group and will be featured in a late-breaking session on October 25 at the American College of Gastroenterology 2023 Annual Scientific Meeting. The late-breaking data to be presented at ACG feature results from children enrolled in the extended active treatment period of a Phase 3 trial, following 16 weeks of Dupixent treatment or placebo in Part A of the trial. All children in Part B were treated with higher or lower dose Dupixent for an additional 36 weeks, providing up to 52 weeks of data. In Part B, there were 37 patients who continued on higher dose Dupixent and 18 who switched from placebo to higher dose Dupixent. Safety results in Part B of the trial were generally consistent with Part A and the known safety profile of Dupixent in its FDA-approved EoE indication for adult and adolescent patients aged 12 years and older who weigh at least 40 kg. AEs reported in greater than or equal to20% of patients who remained on higher dose Dupixent in Part B and those who switched from placebo to higher dose Dupixent in Part B, respectively, included: COVID-19, injection site reaction, cough and headache. In September, the U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for higher dose Dupixent to treat children aged 1 to 11 years with EoE, with a target action date of January 31, 2024. This potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority in this setting.