Health Canada Approves Ozempic® for Cardiovascular Risk Reduction in Type 2 Diabetes
Health Canada has approved the expanded use of Ozempic® (semaglutide injection) to reduce the risk of major adverse cardiovascular (CV) events – including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke – in adults with type 2 diabetes who have established cardiovascular disease and/or chronic kidney disease, Novo Nordisk announced March 2nd.
The approval is based on data from a pooled analysis of four clinical trials: SUSTAIN 6, PIONEER 6, FLOW, and SOUL. These trials demonstrated that treatment with Ozempic® reduced the risk of these cardiovascular events compared to placebo, when added to standard diabetes care. Dr. Lawrence Leiter, Professor of Medicine at the University of Toronto and co-author of the SUSTAIN 6 Trial, stated that the results of cardiovascular outcomes trials have “fundamentally changed the management of diabetes,” demonstrating that therapies like semaglutide can meaningfully reduce cardiovascular risks for those with type 2 diabetes.
Cardiovascular disease is a leading cause of death in Canada, contributing to approximately 40% of heart attacks and 30% of strokes nationwide, according to Novo Nordisk. The expanded indication for Ozempic® addresses a significant health concern for individuals living with type 2 diabetes, who face a substantially higher risk of cardiovascular events than the general population.
The SUSTAIN 6 trial, a 104-week randomized, double-blind, placebo-controlled study involving 3,297 adults with type 2 diabetes and high cardiovascular risk, showed positive outcomes with Ozempic® dosages of 0.5mg and 1mg. The PIONEER 6 trial, involving 3,183 patients with atherosclerotic cardiovascular disease, similarly demonstrated a reduced risk of MACE with Rybelsus®, an oral form of semaglutide. The FLOW trial, focused on patients with type 2 diabetes and chronic kidney disease, indicated that Ozempic® could delay the progression of renal impairment and lower the risk of renal and cardiovascular mortality. Finally, the SOUL trial, encompassing 9,650 patients with type 2 diabetes and established cardiovascular disease or chronic kidney disease, also showed a reduction in MACE with oral semaglutide.
Ozempic® was initially approved by Health Canada in 2018 for the treatment of type 2 diabetes to improve glycemic control. It can be used in conjunction with other medications, including metformin, sulfonylurea, sodium-glucose cotransporter 2 inhibitors (SGLT2i), and basal insulin. In addition to the new cardiovascular indication, Ozempic® is also approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
Iain Graham, General Manager of Novo Nordisk Canada Inc., stated the company is “deeply committed to advancing Ozempic research and delivering innovative treatments that make a meaningful difference for Canadians living with chronic disease.”
As of January 6, 2026, Health Canada is also reviewing submissions for generic versions of semaglutide, the active ingredient in Ozempic and Wegovy, potentially leading to more affordable options for patients. Canada is the first country where Novo Nordisk allowed the patent for its semaglutide drugs to expire, paving the way for generic competition.