FDA Approves Dupixent as First Treatment for Eosinophilic Esophagitis

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) at a dose of 300 mg weekly for patients 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE). This approval makes Dupixent the first and only medicine specifically indicated to treat EoE in the United States.

EoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus, impairing its ability to function properly. For individuals with EoE, swallowing can be painful and anxiety-inducing, often leading to significant dietary restrictions and a reduced quality of life.

The drug, developed by Sanofi and Regeneron, significantly improved signs and symptoms of EoE compared to placebo in a Phase 3 trial. This represents a notable advancement, as patients previously had limited treatment options that did not always provide adequate relief from the condition's debilitating effects.

Regulatory submissions are planned for additional countries by the end of 2022, following a review by the European Medicines Agency. EoE affects an estimated 160,000 patients in the U.S., with approximately 48,000 experiencing ongoing symptoms despite other therapies.