By Stephen Nakrosis


Sanofi and Regeneron Pharmaceuticals Inc. said Wednesday the Food and Drug Administration approved Dupixent to treat patients with prurigo nodularis.

Dupixent, or dupilumab, is the first and only medicine specifically indicated to treat prurigo nodularis, a skin disease that can cause painful lesions, in the U.S. The companies said there are about 75,000 adults in the U.S. living with prurigo nodularis who are most in need of a new treatment option.

According to the companies, "Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials."

Dupixent has also been given regulatory approvals in one or more countries to treat certain patients with atopic dermatitis, asthma and various other ailments. More than 500,000 patients have been treated with Dupixent globally, according to the companies.


Write to Stephen Nakrosis at stephen.nakrosis@wsj.com


Corrections & Amplifications

This article was corrected on Sept. 30, 2022. Sanofi and Regeneron Pharmaceuticals Inc. said there are about 75,000 adults in the U.S. living with prurigo nodularis who are most in need of a new treatment option. The original version incorrectly said the companies said there are about 75,000 adults in the U.S. living with prurigo nodularis.

(END) Dow Jones Newswires

09-28-22 1850ET