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Dupixent® (dupilumab) Phase 3 Trial Shows Positive Results in Children 1 to 11 Years of Age with Eosinophilic Esophagitis
First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent in people with
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilograms\nTrial met its primary endpoint, with 68% of patients on higher dose Dupixent and 58% on lower dose Dupixent achieving histological disease remission at 16 weeks\nFifth pediatric pivotal trial across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent\nTARRYTOWN, N.Y. and PARIS, July 14, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens. There are no approved treatments for children with EoE under 12 years of age.\n\"Dupixent is the first medicine to alleviate key signs of eosinophilic esophagitis in children as young as 1 year of age in a Phase 3 trial. The efficacy of Dupixent demonstrates that in this age group, as in adults, IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this debilitating disease,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. \"Eosinophilic esophagitis can turn the basic and life-sustaining act of eating into a painful experience at a point in children's lives when proper nutrition and achieving a healthy weight is critical to ensuring they grow and thrive. The positive results from this Phase 3 pediatric trial show Dupixent has the potential to improve signs of eosinophilic esophagitis and support healthy weight gain in children from their first birthday.\"\nEoE is a chronic inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and children with EoE demonstrate that IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this disease. In children, common symptoms of eosinophilic esophagitis include acid reflux, vomiting, abdominal discomfort, trouble swallowing, and a failure to thrive. These symptoms can impact grow...