FDA Approves Novo Nordisk’s Ozempic to Reduce Kidney Disease in Patients with Type 2 Diabetes, Chronic Kidney Disease

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The FDA has approved Novo Nordisk’s Ozempic (semaglutide) as the first and only GLP-1 receptor agonist (GLP-1 RA) indicated to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). According to the company, approval was based on data from the Phase IIIb FLOW trial, which demonstrated a significant risk reduction in all three indications compared to placebo.¹

"[CKD] 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, SVP, clinical development, medical & regulatory affairs, Novo Nordisk, in a press release. "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 international, randomized, double-blind, parallel-group, placebo-controlled, event-driven FLOW superiority trial that compared 1 mg of weekly Ozempic with placebo. The trial was conducted at an estimated 400 sites across 28 countries, with 1,767 adults enrolled in the Ozempic group and 1,766 enrolled in the placebo group. The trial’s primary endpoint was a statistically significant and superior risk reduction compared to placebo in the worsening of kidney disease, kidney failure, and cardiovascular disease-related deaths, in addition to standard-of-care.

Results found that Ozempic provided a 24% relative risk reduction in all three outcomes compared to placebo.¹

Serious adverse events (AEs) were less common in the Ozempic group compared to the placebo group. Serious AEs included diabetic retinopathy; COVID-19; cardiovascular disorder; heart failure; acute kidney failure; malignant tumor; and serious gastrointestinal disorder.² Novo Nordisk warns against the use of Ozempic in patients who have a family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, or are allergic to any of the treatment’s ingredients.¹

According to the company, CKD affects approximately 37 million adults in the United States, with the expectation that these numbers will continue to rise as a result of an increased aging population. Current data indicated that 40% of patients with type 2 diabetes also live with CKD.¹

"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, Advent Health Diabetes Institute Orlando, FL, co-chair, FLOW Trial, in the press release. "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."

First approved in 2017 to improve blood sugar in combination with diet and exercise, Ozempic is also indicated to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.¹

References

1. FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. PR Newswire. January 28, 2025. Accessed January 29, 2025. https://www.prnewswire.com/news-releases/fda-approves-ozempic-semaglutide-as-the-only-glp-1-ra-to-reduce-the-risk-of-worsening-kidney-disease-and-cardiovascular-death-in-adults-with-type-2-diabetes-and-chronic-kidney-disease-302362466.html

2. Ozempic® (semaglutide) injection 1 mg demonstrated reduction in risk of kidney disease-related events in Phase 3 FLOW trial presented at the 84th Scientific Sessions of the American Diabetes Association. Novo Nordisk. June 24, 2024. Accessed January 29, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=168527