Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)

Core Insights - The U.S. FDA has approved Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment [1][4][12] - Dupixent is the first new targeted treatment for CSU in over a decade, demonstrating significant reductions in itch and hives in clinical trials [2][4] - The approval is based on data from two Phase 3 clinical trials, which showed Dupixent's efficacy as an add-on therapy to standard antihistamines [2][6] Company Overview - Regeneron Pharmaceuticals, Inc. and Sanofi are the companies behind Dupixent, which is already approved for several other conditions driven by type 2 inflammation [1][12] - Regeneron utilizes its proprietary VelocImmune technology to develop Dupixent, a fully human monoclonal antibody targeting IL-4 and IL-13 pathways [10][30] Clinical Trial Details - The Phase 3 trial program for Dupixent included three studies: Study A (n=136), Study B (n=108), and Study C (n=148), focusing on patients who were symptomatic despite antihistamine use [6][7] - Both Study A and Study C met their primary and key secondary endpoints, showing significant reductions in itch severity and urticaria activity compared to placebo [2][7] - Study B provided additional safety data but did not meet the primary endpoint for itch reduction compared to placebo [8] Patient Impact - More than 300,000 adults and adolescents in the U.S. suffer from CSU that is inadequately controlled by antihistamines, highlighting the need for effective treatment options [1][5] - The approval of Dupixent offers a new treatment avenue for CSU patients, potentially improving their quality of life [2][4] Global Regulatory Status - Dupixent is already approved for CSU in Japan, the UAE, and Brazil, with ongoing reviews in other regions, including the European Union [4][12]