The U.S. Meals and Drug Administration has authorized Dupixent (dupilumab) for the therapy of adults and adolescents with persistent spontaneous urticaria.
The approval is for sufferers 12 years and older who stay symptomatic regardless of histamine-1 antihistamine therapy.
The approval relies on knowledge from two section 3 scientific 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, exhibiting 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 usually in step with the recognized security profile of Dupixent for authorized indications.
“Continual spontaneous urticaria sufferers with uncontrolled illness expertise extremely burdensome itch and hives that may considerably disrupt day by day dwelling,” stated Alyssa Johnsen, M.D., Ph.D., the worldwide therapeutic space head for immunology and oncology growth at Sanofi, in an announcement. “This FDA approval offers a brand new therapy choice to assist tackle the underlying drivers of those extreme and recurring indicators and signs.”
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FDA approves Dupixent for persistent spontaneous urticaria (2025, April 23)
retrieved 24 April 2025
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