Regeneron, Sanofi: Dupixent Hits Endpoints in Chronic Spontaneous Urticaria

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 [e-mail]

(END) Dow Jones Newswires

July 29, 2021 07:00 ET (11:00 GMT)

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