Press release
Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)
Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children Data reinforce the role of type 2 inflammation in EoE and the importance of targeting both IL-4 and IL-13 pathways sBLA for Dupixent to treat children aged 1 to 11 years with EoE is under Priority Review in the U.S.; if approved, Dupixent would be the first and only FDA-approved treatment for these children with EoE PARIS and TARRYTOWN, N.Y., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). 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 (ACG) 2023 Annual Scientific Meeting. “Eosinophilic esophagitis, or EoE, is a chronic and debilitating condition that can impact children in their most vulnerable years of life, causing persistent difficulties with eating, abdominal pain, and/or failure to thrive,” said Mirna Chehade, M.D., MPH, Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York and principal investigator of the trial. “Dupilumab is the first and only therapeutic approved for adults and certain adolescents with EoE. Some children with EoE may have sub-optimal response to currently unapproved standard of care therapies, underscoring the need for treatments targeting key pathways driving inflammation in EoE. Data from this Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is particularly critical for these children.” The late-breaking data to be presented at ACG feature results from children enrolled in the extended active treatment period (Part B) 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 c...