Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).
“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. This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated,” said Anna Windle, senior vice president Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. “With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk’s commitment to cardiometabolic care.”
The FDA approval is based on results from the FLOW phase 3b kidney outcomes trial investigating the effects of once-weekly Ozempic injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.
The FLOW trial achieved its primary endpoint with Ozempic 1mg, demonstrating a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at three years) compared to placebo, when added to standard of care.
“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own 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 (AdventHealth Diabetes Institute, Orlando, USA) co-chair of the FLOW trial. “A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today’s decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients.”
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, Ozempic 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. Today, the FDA has expanded the benefits of Ozempic® to a new patient population that needs critical treatment options to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.
