By Colin Kellaher
Regeneron Pharmaceuticals and Sanofi won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria, or CSU.
Regeneron and Sanofi on Friday said the approval covers Dupixent in people 12 and older who have CSU and remain symptomatic despite histamine-1 antihistamine treatment.
The companies said the green light makes Dupixent the first targeted therapy for CSU in more than a decade, adding that CSU is the seventh disease with underlying type 2 inflammation for which Dupixent is approved.
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 drug internationally. Dupixent global net sales topped $14 billion last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 18, 2025 11:34 ET (15:34 GMT)
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