FDA approves new indication for Novo Nordisk’s Ozempic

Novo Nordisk has received the Food and Drug Administration’s permission for 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.

This approval, along with its existing indications for adults with Type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist in its class, Novo Nordisk said.

"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 of clinical development, medical and 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."

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The company noted that CKD affects approximately 37 million adults in the United States and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure. 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.

"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, medical director at the AdventHealth Diabetes Institute Orlando, Fla., and 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."

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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.