Health Canada has approved Novo Nordisk’s obesity drug Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction (MI).
Wegovy is now approved for adults with established cardiovascular disease and body mass index (BMI) equal to or greater than 27 kg/m2.
It is said to be the first treatment approved for both chronic weight management and lowering the risk of non-fatal MI.
In July this year, the drug received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The latest approval is based on the SELECT trial results, which studied the cardiovascular outcomes of semaglutide in people with overweight or obesity.
SELECT was a randomised, double-blind, placebo-controlled study designed to evaluate the efficacy of semaglutide 2.4 mg in reducing major adverse cardiovascular events (MACE) in people with established cardiovascular disease, overweight, obesity, and no prior history of diabetes.
Participants were aged 45 years or older with a BMI of 27 kg/m² or higher.
The trial demonstrated that Wegovy reduced the risk of MACE by 20% compared to placebo, when used alongside standard care,
SELECT enrolled 17,604 adults across 41 countries at over 800 investigator sites. The study was initiated in 2018 and concluded in 2023.
Overall, the study reported a 15% reduction in cardiovascular death and a 19% reduction in death from any cause.
Novo Nordisk Canada president Vince Lamanna said: “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.”
Health Canada approved Wegovy in 2021 as a once-weekly treatment for obesity, based on data from the STEP clinical trial programme.
In September this year, EMA’s CHMP recommended Wegovy to reduce heart failure-related symptoms in people with obesity-related HFpEF.
Recently, the Danish pharmaceutical firm announced positive results from part 1 of the ongoing Phase 3 ESSENCE trial. It assessed semaglutide in adults with metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis.
