OTTAWA — Health Canada has approved Novo Nordisk’s diabetes drug Ozempic (semaglutide) to reduce the risk of kidney decline, kidney failure, and heart-related deaths in adults with type 2 diabetes and chronic kidney disease. The approval follows results from the international FLOW trial, which showed the drug cut the risk of major kidney disease events and cardiovascular death by 24% compared to placebo.
Ozempic is administered as a once-weekly injection and was initially approved in Canada for lowering blood sugar levels. In addition to its metabolic and cardiovascular benefits, it has been demonstrated to aid in weight loss. It is now the first GLP-1 therapy in Canada authorized to protect both kidneys and the heart in patients with type 2 diabetes. The decision was supported by peer-reviewed trial data published in the New England Journal of Medicine last year.
Between 30% and 50% of people with type 2 diabetes develop some form of chronic kidney disease. Novo Nordisk estimates that about 40% of these patients are affected, representing nearly 4 million people in Canada and 37 million in the U.S.
Dr. David Cherney, a nephrologist at Toronto General Hospital who co-led the Canadian portion of the trial, said to the National Post that the approval marks a major step forward:
“What my patients are scared of is dialysis — dialysis or a transplant. I can reasonably reduce that risk and thereby reduce their anxiety and fear of serious, serious complications. Not to mention all the cardiovascular disease, which patients are also extremely afraid of.”
Dr. Ehud Ur, an endocrinologist at the University of British Columbia who was not involved in the study, called the decision “great news,” noting that Ozempic offers a powerful new tool to prevent kidney decline.
Ozempic has already been cleared in the United States for similar kidney protection benefits. The approval in Canada comes amid a wider race between Novo Nordisk and rival Eli Lilly to expand the use of their blockbuster GLP-1 drugs beyond weight loss and diabetes into other serious conditions.
The U.S. Food and Drug Administration last December approved Lilly’s obesity drug Zepbound for the treatment of obstructive sleep apnea, while last week, Novo’s obesity therapy Wegovy — which contains the same active ingredient as Ozempic — was cleared in the U.S. to treat metabolic dysfunction–associated steatohepatitis, a progressive liver disease.
Doctors caution that some patients may experience gastrointestinal side effects such as nausea, constipation, or diarrhea, and more rarely, gallbladder inflammation or pancreatitis. Still, experts stress that the benefits of slowing kidney disease progression far outweigh the risks for most patients.
“The prevention of kidney disease is a very important goal in the management of patients with Type 2 diabetes and this is another tool” Dr. Ur said.
