FDA Grants Regeneron Approval for Dupixent in Inflammatory Disorder Treatment

By Michael Dabaie

The Food and Drug Administration said it granted to Regeneron Pharmaceuticals Inc. approval of Dupixent to treat inflammatory disorder chronic immune disorder eosinophilic esophagitis.

The FDA approval is for adults and pediatric patients 12 and older.

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus. Common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus.

The FDA originally approved Dupixent in 2017. The drug is approved for moderate-to-severe atopic dermatitis and as an add-on maintenance treatment for 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.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

May 20, 2022 15:27 ET (19:27 GMT)

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