US FDA approves Sanofi & Regeneron Dupixent to treat adults and children aged 12 and older with eosinophilic esophagitis
The US 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. Mary Jo Strobel, executive director, American Partnership for Eosinophilic Disorders (APFED), said:
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