Dupixent® (dupilumab)applicationfor treatment ofchronic spontaneous urticaria (CSU) inadults 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. The U.S. Food and Drug Administration (FDA) has accepted, for review, the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023.
CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. Swelling, called angioedema, may occur most commonly on the…