Press release
Dupixent® (dupilumab) Positive Phase 3 Data in Children 1 to 11 Years of Age with Eosinophilic Esophagitis Published in the New England Journal of Medicine
Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the New England Journal of Medicine (NEJM) has published results from a positive Phase 3 trial for Dupixent® (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Data from the trial were the basis for the U.S. Food and Drug Administration (FDA) Priority Review and approval of Dupixent in children aged 1 to 11 years with EoE weighing at least 15 kg, as well as for the regulatory submission that is currently under review by the European Medicines Agency for this age group. EoE is a chronic, progressive disease associated with type 2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can severely impact a child’s ability to eat and may also cause abdominal pain, trouble swallowing, heartburn, vomiting and failure to thrive. Continuous management of EoE may be needed to reduce the risk of complications and disease progression. “The NEJM publication of these Phase 3 dupilumab results is a testament to the importance of these data and potential for dupilumab to change the standard of care for many young children with eosinophilic esophagitis. These children commonly experience feeding difficulties, food refusal and failure to thrive during a critical time of their growth and development,” said Mirna Chehade, MD, MPH, Mount Sinai Center for Eosinophilic Disorders, Ichan School of Medicine at Mount Sinai, New York, NY, and principal investigator of the trial. “These data showed weight-tiered higher dose dupilumab significantly improved key eosinophilic esophagitis histologic, endoscopic and cellular measures in children as young as 1 year old with sustained results for u...