Health Canada has approved Novo Nordisk's Wegovy (semaglutide injection) for reducing the risk of non-fatal myocardial infarction (MI) in adults with established cardiovascular disease and a body mass index (BMI) of 27 kg/m² or greater. This approval marks Wegovy as the first treatment in Canada authorized for both chronic weight management and the reduction of non-fatal MI risk.
The decision by Health Canada is underpinned by the results of the SELECT trial, a randomized, double-blind, placebo-controlled study. The trial was designed to assess the efficacy of semaglutide 2.4 mg in decreasing major adverse cardiovascular events (MACE) in individuals with pre-existing cardiovascular disease, overweight or obesity, and without a history of diabetes. The study enrolled 17,604 adults across 41 countries, with participants aged 45 years or older and a BMI of 27 kg/m² or higher.
The SELECT trial demonstrated that Wegovy, when used in conjunction with standard care, led to a 20% reduction in the risk of MACE compared to placebo. Key findings from the trial also indicated a 15% reduction in cardiovascular death and a 19% reduction in death from any cause.
Clinical Implications and Expert Commentary
Dr. Jacob Udell, a cardiologist at Women's College Hospital in Toronto, hailed the approval as significant news, expressing hope that it would increase access to the medication for appropriate patients with heart disease, obesity, or overweight. He emphasized the importance of public and private insurers covering the cost of the drug and the need for societal strategies to manage these expenses.
Udell also noted the importance of initiating Wegovy treatment under the supervision of a trained clinician who can properly prescribe the drug and monitor the patient's response to therapy. He cautioned that there are known side effects that require monitoring and potential dose adjustments.
Wegovy's Mechanism and Prior Approvals
Semaglutide, the active ingredient in Wegovy, has been authorized in Canada for treating obesity since 2021. The drug functions by mimicking a naturally occurring hormone in the body that helps to control appetite and food intake, leading to weight loss. The recent approval extends its therapeutic scope to include cardiovascular risk reduction.
The European Union health regulator also recently endorsed the drug for reducing the risk of major cardiovascular events and strokes in overweight or obese adults without diabetes. Wegovy has also received approval in the U.K. and the U.S. for lowering the risk of serious heart problems or strokes in overweight and obese adults.
Novo Nordisk's Perspective
Novo Nordisk Canada president Vince Lamanna stated that the company is very pleased with the approval of Wegovy in Canada for individuals at risk of non-fatal myocardial infarction. He emphasized the profound impact of heart attacks on families across the country and highlighted Wegovy as a clinically evaluated therapy that offers new hope for Canadians living with cardiovascular disease and obesity. Lamanna reiterated Novo Nordisk's commitment to providing Canadians with innovative treatment options to address unmet needs.
