Health Canada has approved Ozempic (semaglutide) to reduce the risk of kidney deterioration in patients with Type 2 diabetes and chronic kidney disease, marking a significant expansion of the drug's therapeutic applications beyond glucose control and weight management.
The regulatory approval, confirmed on August 13, 2024, allows Ozempic to be prescribed "to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease and cardiovascular death in adults with Type 2 diabetes and chronic kidney disease."
Clinical Trial Evidence
The approval was based on results from the international FLOW trial, a randomized controlled study conducted across 28 countries including Canada between 2019 and early 2024. The trial enrolled 3,533 people with diabetes and chronic kidney disease, comparing Ozempic treatment to placebo over an average follow-up period of 3.4 years.
The study demonstrated that patients receiving Ozempic had a 24% lower risk of significant kidney deterioration or failure compared to those receiving placebo injections. Additionally, patients taking the drug showed reduced cardiovascular mortality, addressing another major complication affecting diabetic patients.
"What my patients are scared of is dialysis — dialysis or a transplant," said Dr. David Cherney, a nephrologist at Toronto General Hospital who helped lead the Canadian portion of the trial. "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."
Addressing Unmet Medical Need
The approval addresses a significant clinical need, as between 30 and 50% of people with Type 2 diabetes develop some form of chronic kidney disease. The trial monitored participants for "major kidney disease events," including kidney failure requiring dialysis or transplantation, a 50% reduction in kidney function measured by glomerular filtration rate, or death from kidney-related or cardiovascular causes.
Dr. Ehud Ur, an endocrinologist at the University of British Columbia who was not involved in the study, characterized Health Canada's approval as "great news." He noted that "the prevention of kidney disease is a very important goal in the management of patients with Type 2 diabetes and this is another tool."
First-in-Class Protection
Ozempic represents the first GLP-1 drug approved in Canada to protect both kidneys and heart in patients with Type 2 diabetes. The drug, which is the brand name for injectable semaglutide, was originally approved as a diabetes medication for blood sugar reduction and later approved for weight loss under the brand name Wegovy at higher doses.
"The benefit of Ozempic is that you also get weight loss, which is a very important goal for most people (with Type 2 diabetes). That's a very exciting combination," Ur explained.
Safety Profile and Mechanism
The drug's safety profile includes gastrointestinal side effects such as nausea, vomiting, constipation, and diarrhea. More severe but less common complications can include gallbladder inflammation and pancreatitis, though most side effects are considered minor.
In the FLOW trial, Ozempic was administered alongside participants' existing medications, including drugs to control blood pressure and blood sugar. Despite these standard treatments having beneficial kidney effects, Ozempic demonstrated additional positive impact on kidney function.
"Another weapon against kidney disease is incredibly powerful. And these medicines will often turn patients around who are doing very poorly because it addresses so many different issues — the kidney, the cardiovascular, the metabolic, and the weight," Cherney noted.
Future Research Directions
While the mechanism behind Ozempic's kidney-protective effects remains under investigation, Ur suggested that the drug might reduce inflammation in the kidneys. The FLOW trial results, published in the New England Journal of Medicine and funded by manufacturer Novo Nordisk, underwent peer review before contributing to Health Canada's regulatory decision.
Both experts emphasized the importance of early intervention, with Ur stating that the approval reinforces using the drug "relatively early in the disease process" to minimize kidney damage in people with Type 2 diabetes.
