Health Canada has approved Novo Nordisk’s semaglutide injection, Wegovy, marking it as the first treatment in the country authorised to assist in chronic weight management and to reduce the risk of non-fatal myocardial infarction (MI) in adults with a body mass index (BMI) of 27 kg/m² or greater, who have established cardiovascular disease.
The decision by Health Canada is based on the findings from the randomised, placebo-controlled SELECT trial, a comprehensive study assessing the effectiveness of semaglutide 2.4 mg in preventing major adverse cardiovascular outcomes (MACE) in individuals with cardiovascular disease who are overweight or obese.
The trial, which began in 2018, comprised 17,600 individuals from 41 countries and was conducted across 800 sites.
The double-blind, parallel-group trial aimed to demonstrate the superiority of semaglutide 2.4 mg over placebo in reducing the incidence of three-point MACE, which includes cardiovascular death, non-fatal MI or non-fatal stroke.
Subjects in the trial were adults aged 45 years or older with a BMI [body mass index] of 27 kg/m² or more, without a prior history of diabetes.
The SELECT trial's primary objective was not only to reduce the incidence of MACE but also to evaluate the effects of semaglutide on mortality, cardiovascular risk factors, glucose metabolism, body weight and renal function.
Myocardial infarction, or heart attack, remains the most common manifestation of ischaemic heart disease. In Canada, heart disease is the second leading cause of death and a major reason for hospitalisation.
Novo Nordisk Canada president Vince Lamanna stated: "We are very pleased that Wegovy is now approved in Canada to help people who are at risk of non-fatal myocardial infarction. Heart attacks have a profound impact on many families across our country.
“Wegovy is a clinically evaluated therapy that offers new hope for Canadians living with cardiovascular disease and obesity. We are dedicated to providing Canadians with innovative treatment options to support unmet needs.”
Wegovy is available in more than ten countries. In 2021, Health Canada approved the drug as a once-weekly treatment for people with obesity. This approval was backed by efficacy and safety data from the STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial programme.
In November 2024, the company agreed to collaborate with Ascendis Pharma to develop a once-monthly glucagon-like peptide receptor agonist (GLP-1RA).
