Sanofi Sees Progress for Hives Treatment in EU, Longer U.S. Review for MS Drug

By Billy Gray

France's Sanofi said its Dupixent drug jointly developed with Regeneron advanced toward a new indication for chronic hives in the European Union, while the U.S. Food and Drug Administration extended its review of its multiple sclerosis treatment.

The European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive recommendation for Dupixent to treat chronic spontaneous urticaria in adults and adolescents, Sanofi and Regeneron said Monday. The recommendation is based on results of late-stage studies showing Dupixent significantly reduced itch and hives at 24 weeks compared with a placebo, they said.

If approved, Dupixent would become the first targeted chronic hives treatment available in the EU in more than a decade, the pharmaceutical companies said. The drug is already approved for this indication in the U.S., Japan, and other select countries.

Meanwhile, Sanofi said the U.S. FDA extended by three months its review of its tolebrutinib treatment for non-relapsing secondary progressive multiple sclerosis, an advanced stage of MS where symptoms steadily worsen without breaks or sudden attacks.

The target action date for the agency's decision is now Dec. 28, Sanofi said. The FDA pushed back the date after receiving additional information during the review it considered a major amendment, the company said.

Write to Billy Gray at william.gray@wsj.com

(END) Dow Jones Newswires

September 22, 2025 03:01 ET (07:01 GMT)