FDA Approves Ozempic for Improving CKD Outcomes in Adults with T2D

The FDA has approved semaglutide (Ozempic) to reduce the risk of kidney disease worsening, failure, and death due to cardiovascular disease (CVD) among adult patients who have type 2 diabetes (T2D) and chronic kidney disease (CKD).

As the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) with these indications, Ozempic is now available to treat more conditions than any other medication in its class, according to a Novo Nordisk news release.¹

Now with its CKD indication, Ozempic stands apart from other semaglutide formulas. | image credit: Vector Market / stock.adobe.com

“[CKD] is very serious and common in patients living with [T2D] 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 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.”

READ MORE: SGLT2 Inhibitors Recommended for Treating CKD | ASHP Midyear

Prior to its recent indication, Ozempic was previously approved to increase glycemic control in adults with T2D and reduce cardiovascular event risks in adult patients with known CVD. Now with its CKD indication, Ozempic stands apart from other semaglutide formulas like Rybelsus and Wegovy—which is currently approved to reduce CVD risk and excess weight in patients with obesity.²

“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 [T2D], with approximately 40% of people with [T2D] also experiencing CKD. For people with [T2D], CKD can be a significant burden and can cause additional sickness, including increased risk of cardiovascular problems and death,” continued authors of the release.¹

Novo Nordisk’s FLOW Phase 3b trial investigated how once-weekly Ozempic injections impacted kidney and cardiovascular outcomes among individuals with T2D and CKD. Compared with placebo, the trial met its primary endpoint because of Ozempic’s relative risk reduction of at least 24% for CKD.

"[T2D] can be challenging enough to manage without the added risk of [CKD], and I have seen in my own practice that patients with [T2D] and [CKD] need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard Pratley, MD, Co-Chair of the FLOW Trial.¹ “A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis.”

Across all of its indications, Ozempic—along with other semaglutide formulas—has proven its efficacy in treating CVD, CKD, and T2D collectively. Because obesity, CVD, and CKD are such common complications among T2D patients, Ozempic and GLP-1 RA medications have soared in demand, leading to increased costs and multiple drug shortages.

Ozempic was first approved for improving blood sugar among patients with T2D in 2017 and has since received CVD and CKD approvals. Specifically targeting a population of adults with CKD and T2D, Ozempic is expanding its scope and reaching more patients with different needs.

“Today's decision by the FDA offers hope for the millions of adults living with [T2D and CKD] and provides an additional treatment option, representing a significant advancement for my patients,” Pratley said in the release.¹

READ MORE: Diabetes Resource Center

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

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. News Release. Novo Nordisk, Inc. January 28, 2025. Accessed January 28, 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. FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight. News Release. FDA. March 8, 2024. Accessed January 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or