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# Dupixent Filing for Eosinophilic Esophagitis Next Year
- URL: https://www.fdaweb.com/dupixent-filing-for-eosinophilic-esophagitis-next-year/
- Published: 2022-10-11T12:00:00.000Z
- Updated: 2026-09-14T18:02:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152942

Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating children with active eosinophilic esophagitis (EoE) after announcing positive results from a Phase 3 trial. EoE affects a child’s ability to eat, according to the companies, adding that common symptoms include acid reflux, vomiting, abdominal discomfort, trouble swallowing, and a failure to thrive.

They say the new data support the potential of dupilumab to reduce esophageal damage and “showed histological disease remission and signs of weight gain impacting the growth percentile for those children on higher dose Dupixent.”

Last month, FDA approved Dupixent for treating adult patients with prurigo nodularis, a chronic, debilitating skin disease with underlying Type 2 inflammation. Previously, the therapy was approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.