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  2. Chronic spontaneous urticaria (CSU) causes recurrent itchy hives and/or angioedema, significantly impacting quality of life. Many patients experience a substantial disease burden despite treatment with recommended and escalated doses of H1 antihistamines.

  3. Feb 18, 2006 · A Phase 3 trial (CUPID STUDY B) evaluating Dupixent ® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis.

  4. Jun 29, 2023 · Chronic spontaneous urticaria (CSU) is a condition in which wheals, angioedema, and pruritus occur spontaneously and recurrently for at least 6 weeks. The etiology of this disease is partially dependent on production of autoantibodies that activate and recruit inflammatory cells.

    • 10.1007/s13555-023-00972-6
    • 2023/08
  5. Mar 7, 2006 · Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review. More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines. Paris and Tarrytown, N.Y. March 7, 2023.

  6. Jul 29, 2005 · Download PDF. Dupixent® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients. Fifth disease that Dupixent has demonstrated positive pivotal results.

  7. Mar 7, 2023 · Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older accepted for FDA Review. Regeneron Pharmaceuticals Inc. Published March 7, 2023.

  8. Oct 20, 2023 · The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in chronic spontaneous urticaria (CSU). CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin.

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