Canada has granted approval to Novo Nordisk’s diabetes drug, Ozempic, for reducing the progression of chronic kidney disease (CKD) and lowering the risk of kidney failure and cardiovascular death in people with type 2 diabetes, the company announced.
Ozempic, also known as semaglutide, becomes the first treatment in Canada specifically authorized for type 2 diabetes patients to both improve glycemic control and slow the advancement of kidney disease. The decision from Health Canada was supported by late-stage trial findings indicating that a 1 milligram dose of Ozempic reduced the risk of kidney-related deaths and major cardiac events by 24 percent.
Novo Nordisk highlighted that approximately 40 percent of individuals with type 2 diabetes also have chronic kidney disease. In Canada, CKD impacts about 4 million people, while in the United States, the number stands at 37 million. The company stated that Ozempic is now the only once-weekly treatment approved in Canada to improve blood sugar management and reduce risks tied to kidney disease progression, end-stage kidney failure, and cardiovascular mortality in adults with type 2 diabetes and chronic kidney disease.
The approval is based on results from the FLOW trial, which assessed the protective effects of semaglutide on kidney outcomes in people with type 2 diabetes and CKD. The international, randomized, double-blind, placebo-controlled study enrolled 3,533 participants across 28 countries, including Canada, at roughly 400 sites.
Participants were divided into two groups, with 1,767 receiving semaglutide and 1,766 receiving a placebo, in addition to standard care treatments. The trial, which began in 2019, was stopped early following a recommendation from an Independent Data Monitoring Committee due to demonstrated efficacy.
The FLOW trial met its primary endpoint, showing a 24 percent reduction in the risk of kidney disease progression, cardiovascular death, and kidney mortality for those treated with semaglutide compared to placebo. Specifically, there were 331 events recorded in the semaglutide group compared to 410 in the placebo group, yielding a hazard ratio of 0.76 and a P-value of 0.0003.
Dr. David Cherney, Senior Scientist at Toronto General Hospital Research Institute and Primary Investigator on the FLOW study, emphasized the importance of the findings: “Chronic kidney disease, or CKD, affects 30-50% of people living with type 2 diabetes (T2D), and is associated with a dramatically higher risk of cardiovascular disease and mortality. Fortunately, we have witnessed a significant evolution in the management of CKD in T2D over the last 5 years with the identification of newer therapies that reduce both heart and kidney risk in T2D.”
Dr. Alice Cheng, an endocrinologist at Trillium Health Partners and Unity Health Toronto, noted that many people with type 2 diabetes are unaware they also have CKD. She stated that the FLOW results provide additional evidence that semaglutide is a useful tool in slowing kidney decline while lowering cardiovascular risks.
