FDA approves Novo Nordisk's diabetes drug Ozempic for chronic kidney disease, expanding its use

Core Insights - The FDA approved Novo Nordisk's Ozempic for patients with chronic kidney disease and diabetes, expanding its use in the U.S. [1][2] - Ozempic is already widely used for Type 2 diabetes and now can help reduce the risk of worsening kidney disease, kidney failure, and cardiovascular-related death in affected patients [2][3] Group 1: Drug Efficacy and Impact - The approval could change treatment approaches for chronic kidney disease, which affects around 37 million American adults [3] - Approximately 40% of Type 2 diabetes patients also have chronic kidney disease, increasing their risk of cardiovascular issues and mortality [3][6] - Ozempic reduced the risk of severe kidney outcomes by 24% in diabetic patients with chronic kidney disease compared to a placebo [6] - In patients taking Ozempic, kidney function declined more slowly, with an 18% reduction in major cardiovascular events and a 20% decrease in all-cause mortality [7] Group 2: Clinical Trial and Results - The phase three trial, called FLOW, involved about 3,500 patients and was concluded a year early due to positive results [10] - Serious adverse side effects were reported at 49.6% in Ozempic patients, lower than the 53.8% in the placebo group [9] Group 3: Competitive Landscape and Regulatory Context - The approval comes amid increased competition from Eli Lilly and as Novo Nordisk seeks expanded insurance coverage for its weight loss drug Wegovy [12] - The Biden administration selected three of Novo Nordisk's drugs for Medicare drug price negotiations, including Ozempic [12]