By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria, or CSU.

Regeneron and Sanofi, which are seeking approval of the drug in patients 12 and older whose disease isn't adequately controlled with H1 antihistamine treatment, on Friday said the FDA set a target action date of April 18, 2025, for a decision.

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch.

The companies said an FDA green light would make Dupixent the first targeted therapy for CSU in a decade, adding that more than 300,000 people in the U.S. suffer from the condition, which isn't adequately controlled by antihistamines.

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 companies are targeting Dupixent sales of more than $13.7 billion this year.

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

(END) Dow Jones Newswires

November 15, 2024 06:12 ET (11:12 GMT)

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