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Second Dupixent® (dupilumab) Phase 3 Eosinophilic Esophagitis Trial to Demonstrate Significant Disease Improvements, Underscoring Role of Type 2 Inflammation in This Complex Disease
TARRYTOWN, N.Y. and PARIS, Oct. 25, 2021 /PRNewswire/ -- Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":" TARRYTOWN, N.Y. and PARIS, Oct. 25, 2021 /PRNewswire/ -- \nDupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial\nEosinophilic esophagitis is a progressive disease that damages the esophagus and impairs the ability to swallow; 90% of trial participants had at least one coexisting type 2 inflammatory condition such as asthma or atopic dermatitis\nDupixent is the only biologic medicine to show positive, clinically meaningful Phase 3 results in these patients; regulatory filings planned for 2022\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced results from a second Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. In September 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. \n\"This trial gives insight into how terrible this disease can be, with more than a third of patients having previously required invasive endoscopic dilations that can temporarily reduce symptoms but carry the risk of rupturing the esophagus,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron and a principal inventor of Dupixent. \"Dupixent, which blocks the IL-4 and IL-13 pathways, has now shown compelling results across a spectrum of diseases where there has been great unmet need. In fact, our positive Phase 3 data in six different diseases help confirm our early hypothesis that IL-4 and IL-13 are the main drivers of allergic or type 2 inflammation and disease, whether manifested in the gastrointestinal tract as eosinophilic esophagitis, the respiratory tract as asthma or nasal polyps, or the skin as atopic dermatitis, chronic spontaneous urticaria, or prurigo nodularis.\"\nEoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. At times, swallowing the smallest quantity of food o...