FDA Approves Dupixent for Chronic Spontaneous Urticaria

WEDNESDAY, April 23, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.

The approval is for patients 12 years and older who remain symptomatic despite histamine-1 antihistamine treatment.

The approval is based on data from two phase 3 clinical studies, which included biologic-naïve patients who were symptomatic despite the use of antihistamines. Dupixent was assessed as an add-on therapy to standard-of-care antihistamines versus antihistamines alone. In both studies, Dupixent met the primary and key secondary end points, showing reductions in itch severity and urticaria activity at 24 weeks. Dupixent increased the likelihood of well-controlled disease or complete response at 24 weeks versus placebo. Safety results were generally consistent with the known safety profile of Dupixent for approved indications.

“Chronic spontaneous urticaria patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” Alyssa Johnsen, M.D., Ph.D., the global therapeutic area head for immunology and oncology development at Sanofi, said in a statement. “This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.”

This approval of Dupixent was granted to Sanofi.

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