FDA approves Ozempic to lower kidney and cardiovascular risk in type 2 diabetes and CKD

The FDA on Jan. 28, 2025 approved Ozempic (semaglutide) injection for a new use: reducing the risk of worsening kidney disease, kidney failure (end-stage kidney disease) and death from cardiovascular disease in adults who have both type 2 diabetes and chronic kidney disease ^[3]. Novo Nordisk, which makes the drug, said the decision makes Ozempic the only GLP-1 receptor agonist approved to reduce those risks in this group ^[3][4].

The approval is based on FLOW, a phase 3b trial that compared once-weekly Ozempic 1 mg with placebo in 3,533 adults with type 2 diabetes and chronic kidney disease — 1,767 in the Ozempic group and 1,766 in the placebo group — at about 400 sites in 28 countries ^[3]. All participants received standard care in addition to the study drug ^[3]. The trial began in 2019 and was stopped early on the recommendation of an independent data monitoring committee after a median follow-up of 3.4 years because it had met pre-specified efficacy criteria ^[3].

FLOW showed a 24% relative reduction in the combined endpoint of kidney disease worsening, kidney failure and cardiovascular death, which the company reported as a 4.9% absolute risk reduction at three years ^[3]. One clinical news report described the nearly 5% figure as a reduction in cardiovascular deaths at three years ^[4]; the company release describes it as an absolute risk reduction for the combined kidney and cardiovascular endpoint ^[3]. The results for each individual component of that combined endpoint are not broken out in these accounts.

Kidney disease is common among people with type 2 diabetes. Chronic kidney disease affects about 37 million adults in the United States, and roughly 40% of people with type 2 diabetes also have it ^[3][4]. Diabetes is the leading cause of kidney failure ^[3].

Ozempic was first approved in 2017 to improve blood sugar in adults with type 2 diabetes, and in 2020 it gained an indication to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease ^[1][3]. Its label now lists three uses for the injection, including the kidney indication, which covers a sustained decline in estimated glomerular filtration rate, end-stage kidney disease and cardiovascular death ^[1][5].

The drug's label carries a boxed warning about thyroid C-cell tumors, including medullary thyroid carcinoma, seen in rodents; whether it causes these tumors in people is unknown ^[5]. Other warnings include acute pancreatitis, diabetic retinopathy complications, low blood sugar when used with insulin or sulfonylureas, acute kidney injury due to volume depletion, severe gastrointestinal reactions and gallbladder disease ^[5]. The most common side effects reported in at least 5% of patients are nausea, vomiting, diarrhea, abdominal pain and constipation ^[3][5].

Why it matters for patients

For adults with both type 2 diabetes and chronic kidney disease, the new label gives doctors an approved reason to prescribe Ozempic to lower kidney and cardiovascular risk, not only to control blood sugar ^[3][5]. The people studied were already receiving standard care for their kidney disease, and the benefit was measured on top of that care ^[3].

The label's kidney-related warning is also relevant to this group: nausea, vomiting and diarrhea can cause dehydration, which can lead to kidney problems, and the label advises monitoring kidney function in patients who report reactions that could cause fluid loss ^[5].

Semaglutide is sold under several brand names with different approved uses — Ozempic, Wegovy and Rybelsus — and Novo Nordisk says these products are not interchangeable ^[3]. The kidney indication applies to Ozempic injection. Whether other GLP-1 medicines, or semaglutide products taken for weight loss, produce similar kidney benefits has not been reported.

What happens next

Ozempic is already on the market, so the change is a label expansion rather than a new product launch ^[3]. Whether other drugmakers will seek kidney indications for their GLP-1 medicines has not been disclosed.