Regeneron, Sanofi Get FDA Priority Review for Dupixent

   By Colin Kellaher

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SAN.FR, SNY) on Friday said the U.S. Food and Drug Administration accepted and granted priority review to their supplemental biologics-license application for Dupixent in a chronic upper-airway disease.

The companies said the sBLA covers Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, who often experience recurrence despite previous treatment with surgery or corticosteroids.

Regeneron and Sanofi said there are currently no FDA-approved biologic medicines to treat the disease, which is characterized by polyps that obstruct the sinuses and nasal passages.

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. The agency set a target action date of June 26 for the Dupixent sBLA.

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

March 08, 2019 06:25 ET (11:25 GMT)

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