FDA Approves Dupixent for Chronic Spontaneous Urticaria in Teens and Adults
United States: The U.S. Food and Drug Administration approved Dupixent (dupilumab) for treating chronic spontaneous urticaria among adults together with adolescents, as reported by HealthDay.
The regulatory body approved Dupixent for people aged 12 years and older, except for those experiencing symptoms following antihistamine therapy.
Breakthrough Backed by Strong Clinical Data
Clinical data from two Phase 3 trials served as the basis for the U.S. FDA approval because they included patients who were under active antihistamine treatment yet experienced ongoing symptoms. The clinical assessment evaluated Dupixent as an additional treatment when patients received standard antihistamines compared to antihistamine-only treatment. The clinical tests confirmed that Dupixent achieved both the main goals and key secondary objectives by reducing intense itching and urticaria activity during the 24-week observation period. At week 24, Dupixent significantly improved the probability of patients achieving well-controlled disease along with an all-clear response compared to placebo-treated patients. The observed safety results match the documented safety information for Dupixent when applied for its currently approved uses, as reported by HealthDay.
Breaking News: The #FDA has approved dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria, marking the first new targeted therapy for this condition in over a decade.
— Pharmacy Times (@Pharmacy_Times) April 18, 2025
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A Game-Changer for CSU Patients
“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.”
Sanofi was given permission for Dupixent.
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