By Colin Kellaher

 

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi SA (SAN.FR, SNY) on Tuesday said a phase 3 study of Dupixent to treat severe atopic dermatitis in children ages 6 to 11 met its primary and secondary endpoints.

The study showed that adding Dupixent to standard-of-care topical corticosteroids significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life, the companies said, adding that Dupixent is the first biologic to show positive results in the pediatric population.

Dupixent is approved in the U.S. and European Union to treat people 12 years of age and older with moderate-to-severe atopic dermatitis, the most common form of eczema.

Regeneron and Sanofi said they plan to submit the study results to regulatory authorities, starting with the U.S. Food and Drug Administration in the fourth quarter.

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

August 06, 2019 09:42 ET (13:42 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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