The U.S. Meals and Drug Administration has authorized Dupixent (dupilumab) for the remedy of adults and adolescents with power spontaneous urticaria.
The approval is for sufferers 12 years and older who stay symptomatic regardless of histamine-1 antihistamine remedy.
The approval is predicated on information from two part 3 medical research, which included biologic-naïve sufferers who had been symptomatic regardless of using antihistamines. Dupixent was assessed as an add-on remedy to standard-of-care antihistamines versus antihistamines alone.
In each research, Dupixent met the first and key secondary finish factors, displaying reductions in itch severity and urticaria exercise at 24 weeks. Dupixent elevated the probability of well-controlled illness or full response at 24 weeks versus placebo. Security outcomes had been typically in keeping with the identified security profile of Dupixent for authorized indications.
“Chronic spontaneous urticaria patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” mentioned Alyssa Johnsen, M.D., Ph.D., the worldwide therapeutic space head for immunology and oncology growth at Sanofi, in a press release. “This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.”
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FDA approves Dupixent for power spontaneous urticaria (2025, April 23)
retrieved 23 April 2025
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