FDA approves Dupixent? (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis

發(fā)布時間： 2022-05-30 閱讀：440次

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May 25, 2022-Sanofi and its partner Regeneron jointly 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. This approval represents first indication for Dupixent in a gastrointestinal disease and fourth disease indicated overall. 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.