Regeneron, Sanofi Get CHMP Backing for Dupixent in Eosinophilic Esophagitis

By Colin Kellaher

Regeneron Pharmaceuticals Inc. and Sanofi SA on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of their blockbuster eczema drug Dupixent to treat the chronic inflammatory disease eosinophilic esophagitis.

The companies said the recommendation, which covers people ages 12 and up, is based on study data showing patients on Dupixent experienced significantly improved ability to swallow and achieved histological disease remission compared to placebo.

Regeneron and Sanofi said they expect a final decision from the European Commission, which generally follows the CHMP's advice, in the coming months, adding that a green light would make Dupixent the first and only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.

The commission earlier this week approved Dupixent as the first and only targeted medicine indicated for the chronic skin condition prurigo nodularis.

Regeneron, of Tarrytown, N.Y., created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement. Sanofi markets the product internationally.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 16, 2022 08:08 ET (13:08 GMT)

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