Regeneron, Sanofi Get CHMP Backing for Dupixent in Prurigo Nodularis
11 November 2022 - 11:56PM
Dow Jones News
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
November 11, 2022 07:41 ET (12:41 GMT)
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