Regeneron, Sanofi Get EU Approval For Dupixent in Skin Disease CSU
By Colin Kellaher
Regeneron Pharmaceuticals and Sanofi have won European Commission expanded approval of their blockbuster anti-inflammatory drug Dupixent for certain patients with the inflammatory skin condition chronic spontaneous urticaria, or CSU.
Regeneron and Sanofi on Tuesday said the approval covers Dupixent in people 12 and older who have an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy for CSU.
The companies said the green light makes Dupixent the first targeted therapy in Europe for CSU in more than a decade, adding that Dupixent is now approved for patients across seven chronic, inflammatory diseases in the EU.
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
November 25, 2025 06:14 ET (11:14 GMT)
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