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FDA Approves Dupixent® (dupilumab) as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis
TARRYTOWN, N.Y. and PARIS, May 20, 2022 /PRNewswire/ -- Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, May 20, 2022 /PRNewswire/ --\nDupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of FDA's Priority Review action date\nDupixent 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis compared to placebo in a Phase 3 trial, underscoring the role of type 2 inflammation in this complex disease\nEosinophilic esophagitis is a chronic, progressive inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly\nApproval represents first indication for Dupixent in a gastrointestinal disease and fourth disease indicated overall\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. A regulatory filing for EoE is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are planned by the end of 2022.\n\"We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis – an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow,\" said Mary Jo Strobel, Executive Director at the American Partnership for Eosinophilic Disorders (APFED). \"Before today, there were no approved treatments specifically for eosinophilic esophagitis, resulting in many people needing to maintain a strict diet and live in constant fear of food getting stuck in their throat. We welcome therapeutic options that can provide much-needed relief for these patients.\" \nEoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depressio...