Regeneron, Sanofi Get CHMP Backing for Dupixent in Younger Children With CSU

By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi said a key European regulatory committee has recommended expanded approval of their blockbuster anti-inflammatory drug Dupixent for younger patients with the inflammatory skin condition chronic spontaneous urticaria, or CSU.

Regeneron and Sanofi on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers Dupixent in children ages 2 to 11 with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy for CSU.

The European Commission, which generally follows CHMP's advice, is expected to make a final decision in the coming months, the companies said.

Regeneron and Sanofi last year won European approval of Dupixent for people 12 and older with CSU.

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 reached about $18.5 billion last year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

02-27-26 0738ET