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Dupixent® (dupilumab) is the First Biologic to Significantly Reduce Itch and Skin Lesions in Phase 3 Trial for Prurigo Nodularis, Demonstrating the Role of Type 2 Inflammation in this Disease
TARRYTOWN, N.Y. and PARIS, Oct. 22, 2021 /PRNewswire/ -- Pivotal trial met primary and all key secondary endpoints Dupixent significantly reduced itch at 12
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, Oct. 22, 2021 /PRNewswire/ --\nPivotal trial met primary and all key secondary endpoints\nDupixent significantly reduced itch at 12 weeks, and nearly three times as many Dupixent patients experienced reductions in both itch and skin lesions at 24 weeks\nPrurigo nodularis, the sixth disease where Dupixent has demonstrated positive Phase 3 results, is a chronic skin condition that causes extreme itch and inflammatory skin lesions (nodules) \nData reinforce impact of targeting IL-4 and IL-13, key and central drivers of type 2 inflammation, to address itch and skin lesions\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal Phase 3 results from a trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions. The trial met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch. \n\"Prurigo nodularis is an underdiagnosed disease with immense physical and emotional burden for the 74,000 people in the U.S. who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. \"These patients are left to cope with severe itching and painful nodules that, in turn, significantly impair one's quality of life with many resorting to immunosuppressants and some to antidepressants. These results show – for the first time in a Phase 3 prurigo nodularis trial – that a systemic medicine was able to address the most debilitating symptoms such as itch without broadly suppressing the immune system, building on the promise of Dupixent in a broad range of serious dermatologic, respiratory and gastrointestinal diseases.\"\nPeople with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. It is often described as painful with burning, stinging and tingling of the skin. The debilitating signs and symptoms of prurigo n...