FDA Approves First EoE Treatment

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) as the first treatment for eosinophilic esophagitis (EoE) in individuals aged 12 years or older who weight at least 40 kilograms.

The approval was based upon a randomized, placebo-controlled trial that was made up of two 24-week treatment periods (Part A and Part B). All patients received 300 mg of dupilumab or placebo weekly. Efficacy was measured through a certain level of reduced eosinophils in the esophagus at week 24 and change in the Dysphagia Symptom Questionnaire (DSQ) scores reported by patients from baseline to week 24.

The results of Part A indicated that 60% of the 42 patients achieved the level of reduced eosinophils, compared with 5% of the 39 patients who received placebo. The dupilumab patients in Part A had an average improvement of 22 points in their DSQ, compared with 10 points for those who received placebo.

Similarly in Part B, the level of reduced eosinophils was achieved in 59% of 80 patients who received dupilumab and 6% of 79 patients who received placebo. There was also an average improvement of 24 points and 14 points in the DSQ scores, respectively.

Injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections were among the adverse effects associated with dupilumab. Individuals with known hypersensitivity to dupilumab or any of its active ingredients should not use this medication. This medication should also not be used in individuals with certain parasitic infections or in conjunction with live vaccinations. Warnings include the potential development of allergic reactions, conjunctivitis, keratitis, or joint pain.

This medication was previously approved in 2017 for the treatment of moderate to severe atopic dermatitis, and as an add-on maintenance treatment for certain types of moderate to severe asthma and poorly controlled chronic rhinosinusitis with nasal polyposis.

—Leigh Precopio

Reference:

FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder. News release. US Food and Drug Administration; May 20, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-eosinophilic-esophagitis-chronic-immune-disorder