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FDA Approves Dupixent for Chronic Spontaneous Urticaria

  • The U.S. Food and Drug Administration approved Dupixent for chronic spontaneous urticaria in adults and adolescents 12 and older on April 18, 2025.
  • This approval was based on data from two Phase 3 clinical studies involving patients who remained symptomatic despite standard antihistamine treatment.
  • The trials assessed Dupixent as an add-on therapy in biologic-naïve patients aged 12 years and older.
  • Both studies met primary endpoints, demonstrating reductions in itch severity and increased likelihood of well-controlled disease at 24 weeks.
  • The clearance provides a new treatment option for over 300,000 eligible U.S. Patients and represents Dupixent's seventh FDA-approved indication.
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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.

·Calhoun, United States
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biopharmadive.com broke the news in on Friday, April 18, 2025.
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