FDA Approves First Treatment for Eosinophilic Esophagitis

The U.S. Food and Drug Administration on May 20 approved the monoclonal antibody dupilumab to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. This marks the FDA’s first approval of a treatment for EoE.

EoE is a chronic inflammatory disorder that causes difficulty swallowing and eating. Dupilumab acts to inhibit part of the pathway that causes eosinophils to build up in the tissues of the esophagus, causing inflammation.

Patients in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial of two 24-week treatment periods patients received either placebo or 300 milligrams of dupilumab weekly. Primary endpoints were the proportion of patients who achieved a specific reduction of eosinophils in the esophagus at week 24, and the change in the patient-reported Dysphagia Symptom Questionnaire (DSQ) score from baseline to week 24.

In the 2-part trial, 59% to 60% of the patients who received dupilumab achieved the predetermined level of reduced eosinophils in the esophagus compared to 5% to 6% of patients who received a placebo. Patients who received dupilumab also experienced an average improvement of 22 to 24 points in their DSQ score compared to 10 to 14 points in patients who received placebo.

Dupilumab has been approved since 2017 for treatment of moderate-to-severe atopic dermatitis and certain types of moderate to severe asthma.

—Rebecca Mashaw

Reference:

FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder. Press release. US Food and Drug Administration; May 20, 2022. Accessed May 26, 2022.