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Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Eosinophilic Esophagitis
If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 years and older with eosinophilic esophagitis in
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 years and older with eosinophilic esophagitis in the European Union \nIn the U.S., Dupixent is currently the only medicine indicated to treat eosinophilic esophagitis\nApproval recommendation based on pivotal trial data demonstrating patients on Dupixent 300 mg weekly experienced significantly improved ability to swallow and achieved histological disease remission compared to placebo\nIn the European Union, about 50,000 adults and adolescents live with severe uncontrolled eosinophilic esophagitis\nTARRYTOWN, N.Y. and PARIS, Dec. 16, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE). This positive opinion covers those who are 12 years and older, weighing at least 40 kg, and inadequately controlled by, are intolerant to or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In May 2022, Dupixent 300 mg weekly was approved by the U.S. Food and Drug Administration for the treatment of patients aged 12 years and older, weighing at least 40 kg.\nEoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. 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 depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition.\nThe pos...