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

• Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of FDA’s Priority Review action date
• Dupixent 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis compared to placebo in a Phase 3 trial, underscoring the role of type 2 inflammation in this complex disease
• Eosinophilic esophagitis is a chronic, progressive inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly
• Approval represents first indication for Dupixent in a gastrointestinal disease and fourth disease indicated overall

Paris and Tarrytown, N.Y. May 20, 2022. 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. 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.

This is an exciting development for all those affected around the globe, especially those that have remained unsuccessful in remission of symptoms despite other treatments.

Read the full press release.

Read about Part A and Part C of the clinical trials that lead to this approval.