FDA approves Semaglutide for renal protection among diabetes patients with CKD

Novo Nordisk has announced that the Food and Drug Administration (FDA) has approved semaglutide (Ozempic) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular-related death in adults with type 2 diabetes and chronic kidney disease (CKD), making it the only GLP-1 receptor agonist with this indication.

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 (GLP-1 RA) in its class.

"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, PhD, 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."

CKD affects approximately 37 million adults in the U.S. and is expected to rise with an aging demographic and increasing prevalence of diabetes, the leading cause of CKD and kidney failure. CKD is a common complication of type 2 diabetes, with approximately 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.

This 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.1 The FLOW trial achieved its primary endpoint with Ozempic 1 mg, 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 3 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, MD, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, 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."

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.

Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic.

About FLOW

FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing once-weekly Ozempic 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR < 15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, and CV death in adults with type 2 diabetes and CKD. 3,533 adults (1,767 in the Ozempic group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at approximately 400 investigator sites. The FLOW trial was initiated in 2019. At the recommendation from an Independent Data Monitoring Committee, the FLOW study was stopped early due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.

What is Ozempic

Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes

• 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

• 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

It is not known if Ozempic is safe and effective for use in children.