Health Canada Approves Ozempic® (semaglutide injection) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) in Adults with Type 2 Diabetes Français
- Ozempic® is indicated as an adjunct to diet, exercise, and standard of care to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease.1
- Ozempic® indication expansion is based on positive outcomes observed from the pooled analysis of SUSTAIN 6, PIONEER 6, FLOW and SOUL, which demonstrated a reduction in the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk.1
- Cardiovascular disease is the second-leading cause of death in Canada.2
MISSISSAUGA, ON, March 2, 2026 /CNW/ - Novo Nordisk announced today that Health Canada has approved Ozempic® (semaglutide injection) to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease and/or chronic kidney disease.1
Health Canada's new indication approval is based on results from the pooled analysis of SUSTAIN 6, PIONEER 6, FLOW and SOUL that demonstrated treatment with Ozempic® reduced the risk of major adverse cardiovascular events (MACE) compared to placebo, when used in addition to standard of care.1
"Adults with type 2 diabetes face a substantially higher risk of heart attacks and other major cardiovascular events than the general population," said Dr. Lawrence Leiter, Professor of Medicine, University of Toronto, and co-author of the SUSTAIN 6 Trial. "Over the past decade, the results of cardiovascular outcomes trials such as SUSTAIN 6 have fundamentally changed the management of diabetes, as they have demonstrated that therapies like semaglutide can meaningfully reduce the risk of major cardiovascular events, including heart attacks and non-fatal strokes, in people living with type 2 diabetes with, or at high risk of, cardiovascular disease. This represents an important advance for persons living with diabetes and their families."
In Canada, type 2 diabetes has a significant impact on cardiovascular health. It is estimated that type 2 diabetes contributes to approximately 40% of heart attacks and 30% of strokes nationwide.3 Clinical data highlights the importance of addressing cardiovascular risk as part of comprehensive disease management.5
"We are deeply committed to advancing Ozempic research and delivering innovative treatments that make a meaningful difference for Canadians living with chronic disease. By addressing cardiovascular risk in people with type 2 diabetes, we are helping move chronic disease care forward and supporting better outcomes for patients," said Iain Graham, General Manager, Novo Nordisk Canada Inc.
About the Clinical Trials
SUSTAIN 64 was a 104-week, randomized, double-blind, placebo-controlled cardiovascular outcomes trial evaluating Ozempic® (semaglutide injection) in 3,297 adults with type 2 diabetes and high cardiovascular risk. Patients received once-weekly Ozempic® 0.5mg or 1 mg, or placebo, in addition to standard of care. The primary objective of the trial was to confirm that treatment with semaglutide does not result in any unacceptable increase in cardiovascular risk as compared to placebo in adults with type 2 diabetes. This was assessed by evaluating time to first occurrence of a major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
PIONEER 65 was a multi-center, multi-national, placebo-controlled, double-blind trial. In this trial, 3,183 adult patients with inadequately controlled type 2 diabetes mellitus and atherosclerotic CV disease were randomized to Rybelsus® 14 mg once daily or placebo for a median observation time of 16 months. The trial compared the risk of a MACE between Rybelsus® 14 mg and placebo when added to current standard of care treatments for diabetes and CV disease. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included CV death, non-fatal MI and non-fatal stroke.
FLOW6 was a multi-center, multi-national, randomized, placebo-controlled, double-blind, parallel-group, event driven trial in adults with type 2 diabetes and chronic kidney disease. A total of 3533 patients were randomized to receive Ozempic® 1 mg once weekly or placebo and were followed for a median of 40.9 months. The primary objective of FLOW was to demonstrate that Ozempic® delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and chronic kidney disease.
SOUL7 was a randomized, double-blind, parallel-group, placebo-controlled trial. In this trial, 9650 patients with type 2 diabetes mellitus and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD), were randomized to either oral semaglutide 14 mg once daily or placebo once daily. The trial compared the risk of major adverse cardiovascular event (MACE) between oral semaglutide and placebo when these were added to and used concomitantly with standard of care treatments for diabetes and cardiovascular disease. The primary endpoint, MACE, was the time to first occurrence of a three-component composite outcome which included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
About Ozempic
Ozempic® was approved by Health Canada in 2018. Ozempic® is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control.
Ozempic® can be used with metformin, sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and basal insulin with metformin. Ozempic® is also indicated:
- as an adjunct to diet, exercise, and standard of care to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease.
- to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
For information about Ozempic®, including important safety information, please view the product monograph here.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.ca, Facebook, Instagram, X, LinkedIn and YouTube.
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1 Novo Nordisk Canada Inc. (February 25, 2026). Ozempic® Product Monograph. |
2 Increasing Prevalence and Incidence of Atherosclerotic Cardiovascular Disease in Adult Patients in Ontario, Canada From 2002 to 2018 Mackinnon, Erin S. et al. CJC Open, Volume 4, Issue 2, 206 – 213. https://www.cjcopen.ca/article/S2589-790X(21)00272-9/fulltext |
3 Diabetes Canada. Diabetes in Canada: Backgrounder. Toronto: Diabetes Canada; 2024. Available from: https://diabetes.ca/advocacy-policies/advocacy-reports/national-and-provincial-backgrounders/diabetes-in-canada |
4 Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Authors: Steven P. Marso, M.D., Stephen C. Bain, M.D., Agostino Consoli, M.D., Freddy G. Eliaschewitz, M.D., Esteban Jódar, M.D., Lawrence A. Leiter, M.D., Ildiko Lingvay, M.D., M.P.H., M.S.C.S., +8. Published November 10, 2016. N Engl J Med. VOL. 375 NO. 19 DOI: 10.1056/NEJMoa1607141 |
5 Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. Authors: Mansoor Husain, M.D., Andreas L. Birkenfeld, M.D., Morten Donsmark, Ph.D., Kathleen Dungan, M.D., M.P.H., Freddy G. Eliaschewitz, M.D., Denise R. Franco, M.D., + et al. Published June 11, 2019. N Engl J Med. 2019; 381:841–851. |
6 Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. Authors: Vlado Perkovic, M.B., B.S., Ph.D., Katherine R. Tuttle, M.D., Peter Rossing, M.D., D.M.Sc., Kenneth W. Mahaffey, M.D., Johannes F.E. Mann, M.D., George Bakris, M.D., + et al. Published May 24, 2024. N Engl J Med. 2024. DOI: 10.1056/NEJMoa2403347 |
7 Oral Semaglutide and Cardiovascular Outcomes in High‑Risk Type 2 Diabetes. Authors: Darren K. McGuire, M.D., Nikolaus Marx, M.D., Sharon L. Mulvagh, M.D., Stephen C. Bain, M.D., John E. Deanfield, M.D., Johannes F.E. Mann, M.D., + et al. Published March 29, 2025. N Engl J Med. 2025. DOI: 10.1056/NEJMoa250XXXX (final DOI assigned March 2025) |
SOURCE Novo Nordisk Canada Inc.
Contact for further information: Novo Nordisk Canada, Jaclyn Crawford, 647-201-6817, [email protected]; Kate Hanna, 905-301-7334, [email protected]
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