By Colin Kellaher


Regeneron Pharmaceuticals Inc. and Sanofi SA on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of their blockbuster eczema drug Dupixent to treat adults with moderate-to-severe prurigo nodularis.

The companies said the recommendation is based a pair of pivotal studies in which Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with the chronic skin condition.

Regeneron and Sanofi said they expect a final decision from the European Commission, which generally follows the CHMP's advice, in the coming months, adding that a green light would make Dupixent the first and only targeted medicine specifically indicated for prurigo nodularis in the European Union.

Regeneron, of Tarrytown, N.Y., created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement. Sanofi markets the product internationally.

The U.S. Food and Drug Administration in September approved Dupixent for adults with prurigo nodularis.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

11-11-22 0741ET