HQ Team
January 29, 2025: Novo Nordisk’s medicine has been approved by the US drug regulator for reducing the risk of kidney failure and death due to cardiovascular disease in diabetic adults with chronic kidney disease.
The Ozempic (semaglutide) injection’s extended approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control, “establishes it as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class,” according to a statement.
The US Food and Drug Administration’s approval was based on results from an end-stage trial that investigated the effects of once-weekly Ozempic injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and chronic kidney disease (CKD).
The trial achieved its primary endpoint with Ozempic, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure, and death due to cardiovascular disease compared to a placebo when added to the standard of care treatment.
CKD common in diabetics
“Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities,” said Anna Windle, PhD, Senior Vice President Clinical Development, Medical & Regulatory Affairs at Novo Nordisk.
The approval “allows us to more broadly address conditions within the cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated.”
Chronic kidney disease affects about 37 million adults in the US and is expected to rise with an ageing demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure.
CKD is a common complication of type 2 diabetes, with about 40% of people with type 2 diabetes also experiencing CKD. For people with type 2 diabetes, CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death.
Medications for support
“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes,” said Richard E. Pratley, MD, co-chair of the Trial.
The FDA initially approved Ozempic in 2017 to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes.
In 2020, the medicine was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.
830 million worldwide
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves.
The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin, according to the WHO.
About 830 million people worldwide have diabetes, the majority living in low-and middle-income countries. More than half of people living with diabetes are not receiving treatment, according to the global health agency.
