Regeneron, Sanofi: Dupixent Hits Endpoints in Chronic Spontaneous Urticaria
July 29 2021 - 07:15AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. and Sanofi SA Thursday said a
pivotal Phase 3 study of their blockbuster eczema drug Dupixent met
its primary and all key secondary endpoints in patients with
moderate-to-severe chronic spontaneous urticaria, an inflammatory
skin disease.
The companies said adding Dupixent to standard-of-care
antihistamines significantly reduced itch and hives for
biologic-naive patients compared to antihistamines alone at 24
weeks in the study, the first of two trials of their clinical
program.
Regeneron and Sanofi said chronic spontaneous urticaria is the
fifth disease in which Dupixent has shown positive pivotal results,
adding that the study data continue to support the drug's safety
profile.
The companies said the expect a readout from the second study,
which will evaluate Dupixent in adults and adolescents who remain
symptomatic despite standard-of-care treatment and are intolerant
or incomplete responders to an anti-IgE therapeutic, in the first
half of 2022, and that they expect to begin regulatory submissions
next year.
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 29, 2021 07:00 ET (11:00 GMT)
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