The US Food and Drug Administration has approved dupixent (dupilumab) for the treatment of adults and adlescents with chronic spontaneous urticaria.

The approval is for patients 12 years and older who remptomatic despite history-1 antihistamine treatment.

The approval is based on data from two phase 3 Clinical Studies, which included biologic-unives patients who were symptomatic despits the use of antihistamines. Dupixent was assessed as an add-on therapy to standard-of-care antihistamines versus antihistamines alone.

In Both Studies, Dupxent met the primary and key secondary end points, showing Reductions in itch Severity and Urticaria Activity at 24 Weeks. Dupixent increases the likelihood of well-contrared disease or complete responses at 24 weeks versus placebo. Safety results were generally consistent with the knowledge safety profile of dupixent for approved indications.

“Chronic spontaneous urticaria patients with unconstrolled disease highly burdensome itch and hives that can significantly disrupt daily liveings,” Said Alyssa Johnsen, Md, Ph.D., The Global Therapeutic Area Head for Immunology and Oncology Development at Sanofi, in a statement. “This FDA Approval Provides a new treatment option to help address the underling drivers of these severe and recurring signs and symptoms.”

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