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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
TARRYTOWN, N.Y. and PARIS, July 29, 2021 /PRNewswire/ -- Fifth disease in which Dupixent has demonstrated positive pivotal results Phase 3 trial met primary
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, July 29, 2021 /PRNewswire/ --\nFifth disease in which Dupixent has demonstrated positive pivotal results\nPhase 3 trial met primary and all key secondary endpoints at 24 weeks, showing Dupixent nearly doubled reduction in itch and urticaria activity scores \nCSU results further demonstrate the potential of targeting IL-4 and IL-13 via IL-4Ra blockade to improve diseases with components of type 2 inflammation\nApproximately 300,000 people in the U.S. have moderate-to-severe CSU that does not respond adequately to antihistamines alone\nData continue to support well-established safety profile of Dupixent\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program.\n\"This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. \"These data add to the increasing body of evidence that Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases. By early 2022, we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well as other trial results in additional dermatologic diseases.\"\nCSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, and can also affect the throat and upper airways. CSU is typically treated ...