Health Canada approves Ozempic® to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

Health Canada’s CKD indication for Ozempic^® is based on the results of the FLOW trial.  The dedicated kidney outcomes trial was designed to determine the kidney-protective effects of semaglutide in participants with CKD and T2D, as well as assessing the effect of CVD mortality. The FLOW trial achieved its primary endpoint, with semaglutide 1 mg demonstrating a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo (331 vs. 410 events; hazard ratio: 0.76 [0.66; 0.88]; P=0.0003).³

About the FLOW Trial
FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing injectable semaglutide 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the risk of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD (defined as eGFR² ≥50 and ≤75mL/min/1.73 m² and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m² and UACR >100 and <5000 mg/g). 3,533 people (1,767 in the semaglutide group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries, including Canada, at around 400 investigator sites. The FLOW trial was initiated in 2019,¹ and was stopped early due to efficacy, based on a recommendation from an Independent Data Monitoring Committee.

The key objective of the FLOW trial was to demonstrate delay in the progression of CKD and a lower risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI³ equation compared with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m², initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease or death from cardiovascular disease. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and all-cause death.¹

About CKD and T2D 
CKD is a major health problem affecting approximately 4 million Canadians.⁴ It is defined as the presence of kidney damage, or a decreased level of kidney function, for a period of three months or more. It can often start slow and develop without symptoms over a number of years and may not be detected until it has progressed to the point where kidney function is low. Kidney disease can be a devastating complication, as it is associated with significant reductions in both length and quality of life.⁵ Around 40% of people with type 2 diabetes (T2D) will develop chronic kidney disease (CKD),⁶ however, CKD is asymptomatic in its early stages and is under-diagnosed in people with T2D.⁷ Renal function decline increases the probability of multi-morbidity as well as excess mortality.⁸ T2D, CKD and cardiovascular disease (CVD) are interconnected.⁹

About Ozempic
Ozempic^® is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control. It was approved by Health Canada in 2018. Ozempic^® can be used with metformin, sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and basal insulin with metformin. Ozempic^® is also indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.¹⁰ For information about Ozempic^®, including important safety information, please view the product monograph here.

About Novo Nordisk 
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.ca, Facebook, Instagram, X, LinkedIn and YouTube.

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SOURCE Novo Nordisk Canada Inc.

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