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Second Positive Phase 3 Dupixent® (dupilumab) Trial Confirms Significant Improvements for Patients with Prurigo Nodularis
TARRYTOWN, N.Y. and PARIS, Jan. 19, 2022 /PRNewswire/ -- Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis,
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, Jan. 19, 2022 /PRNewswire/ --\nDupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesions\nData confirm results from first Phase 3 trial, with 60% of Dupixent patients meeting the primary endpoint of itch reduction compared to 18% of placebo patients at 24 weeks\nAdditionally, nearly three times as many Dupixent patients experienced reduced skin lesions\nData continue to support well-established safety profile of Dupixent\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal results from a second Phase 3 trial, PRIME, evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease. The trial met its primary and key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. These data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial, and are expected to be submitted to regulatory authorities around the world starting in the first half of this year.\n\"Prurigo nodularis is a highly burdensome disease involving dozens, if not hundreds of incessantly itchy and burning skin lesions, and the potential for complications such as skin infections,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. \"The results of this trial once again show that Dupixent is able to significantly address the hallmark symptoms of this disease while maintaining a consistent safety profile, including a numerically lower rate of skin infections. We are encouraged by the progress of our extensive Dupixent development program that continually reinforces IL-4 and IL-13 as key drivers of the type 2 inflammation underlying a number of diseases, including dermatological diseases such as prurigo nodularis and atopic dermatitis, respiratory diseases such as asthma and chronic rhinosinusitis with nasal polyps, and gastrointestinal diseases such as eosinophilic esophagitis.\"\nPeople with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover m...