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# FDA Approves Dupixent for Eosinophilic Esophagitis
- URL: https://www.fdaweb.com/fda-approves-dupixent-for-eosinophilic-esophagitis/
- Published: 2022-05-20T12:00:00.000Z
- Updated: 2026-09-14T17:45:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151862

FDA has approved Regeneron’s Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the esophagus, according to an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-eosinophilic-esophagitis-chronic-immune-disorder?ref=fdaweb.com). Symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus.  

Approval was based on data from a randomized, double-blind, parallel-group, multicenter, placebo-controlled [trial](https://secure-web.cisco.com/1oETXPZb-qChI2jB0pJJHNoXFw6PWfdIeGpgSTAxAJkIfDoeV-KcddNAP3ZVUTYRfSMRQ59s5dh91qpu875EuUqWHcefq4KplUsndAA1wqxPXu60kM3jjrSZM3B81QV7RtQwe70x53fEmuFSYXDCtHmQRzU1gTqOTnqeSNuYRiArDJSDdZlaM9tUaG2xTLjoeWnghDhBLcffB6xWo08Q47Q/https%3A%2F%2Flnks.gd%2Fl%2FeyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA1MjAuNTgyNDE0MDEiLCJ1cmwiOiJodHRwczovL2NsaW5pY2FsdHJpYWxzLmdvdi9jdDIvc2hvdy9OQ1QwMzYzMzYxNz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.ik-ioS8Okbw1sHsxjWAwMpzBLp4a50rkdR8KipM09yg%2Fs%2F1256267564%2Fbr%2F131674440620-l?ref=fdaweb.com), that included two 24-week treatment periods (Part A and Part B) that were conducted independently in separate patient groups. “In Part A of the trial, 60% of the 42 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the esophagus compared to 5% of the 39 patients who received a placebo,” FDA says. “In Part B, 59% of the 80 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the esophagus compared to 6% of the 79 patients who received a placebo.”  

Dupixent was originally approved in 2017 for treating moderate-to-severe atopic dermatitis in adult and pediatric patients. It is also approved as an add-on maintenance treatment for adults and pediatric patients aged 6 and older with certain types of moderate-to-severe asthma, as well as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.