SNY Sanofi

   By Colin Kellaher 
 

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi S.A. (SAN.FR, SNY) on Tuesday said the U.S. Food and Drug Administration accepted for priority review a supplemental biologics license application for Dupixent to treat eczema in adolescents.

The companies said the sBLA covers Dupixent in patients ages 12 to 17 with moderate-to-severe atopic dermatitis, or eczema, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.

The FDA, which approved Dupixent for adults in March 2017, has set a target action date of March 11, 2019, for the decision on adolescents.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Regeneron and Sanofi said there are currently no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis.

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, which markets the product internationally, last week said third-quarter sales of Dupixent nearly tripled to about $257 million, including U.S. sales of about $216 million.

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

(END) Dow Jones Newswires

November 06, 2018 10:59 ET (15:59 GMT)

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