By Colin Kellaher
Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for adults with the chronic skin disease bullous pemphigoid.
Regeneron and Sanofi on Tuesday said the speedy FDA review is based on study results showing significant improvements in sustained disease remission with Dupixent compared with placebo.
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. The agency has set a target action date of June 20 for the application.
Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesions.
Tarrytown, N.Y., biotechnology company Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the product internationally. The drug generated more than $13.5 billion in sales last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 18, 2025 06:10 ET (11:10 GMT)
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