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

The U.S. Food and Drug Administration has approved Ozempic (semaglutide) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease) and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease, Novo Nordisk said on Jan. 28, 2025 ^[1]. The company says Ozempic is the only GLP-1 receptor agonist approved to reduce those risks ^[1].

The new indication covers Ozempic injection at 0.5 mg, 1 mg and 2 mg ^[1]. It sits alongside two earlier approvals: improving blood sugar in adults with type 2 diabetes, granted in 2017, and reducing the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease, granted in 2020 ^[1].

The decision rests on FLOW, a phase 3b kidney outcomes trial that compared once-weekly Ozempic 1 mg with placebo, each added to standard of care ^[1]. FLOW enrolled 3,533 adults — 1,767 in the Ozempic group and 1,766 in the placebo group — across 28 countries at about 400 investigator sites, starting in 2019 ^[1]. An independent data monitoring committee recommended stopping the trial early because it had met pre-specified efficacy criteria; the median follow-up was 3.4 years ^[1].

Ozempic 1 mg produced a 24% relative risk reduction in the primary composite endpoint of kidney disease worsening, kidney failure and cardiovascular death, compared with placebo, which the company reported as a 4.9% absolute risk reduction at three years ^[1]. That composite included a sustained decline in eGFR of 50% or more, a sustained eGFR below 15 mL/min/1.73 m2, chronic renal replacement therapy, kidney death and cardiovascular death ^[1].

Chronic kidney disease affects about 37 million adults in the United States, and about 40% of people with type 2 diabetes also have it, according to the company ^[1]. "Chronic kidney disease is very serious and common in patients living with type 2 diabetes," said Anna Windle, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk ^[1]. Richard E. Pratley, medical director at the AdventHealth Diabetes Institute in Orlando, Florida, and co-chair of FLOW, said in the announcement that the decision "offers hope for the millions of adults living with both conditions and provides an additional treatment option" ^[1].

The Ozempic label carries warnings for thyroid tumors including cancer, pancreatitis, vision changes, low blood sugar, dehydration that can lead to kidney problems, severe stomach problems, serious allergic reactions, gallbladder problems, and food or liquid entering the lungs during anesthesia or deep sedation ^[1]. The most common side effects listed are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1]. The label says it is not known whether Ozempic is safe and effective in children ^[1].

Why it matters for patients

Adults who have both type 2 diabetes and chronic kidney disease now have a GLP-1 medicine whose label names kidney decline and cardiovascular death as outcomes it is approved to reduce, rather than blood sugar alone ^[1]. In FLOW, the drug was given on top of standard of care, so the approval adds an option rather than replacing existing kidney or diabetes treatment ^[1].

Kidney disease is common in this group: about 40% of people with type 2 diabetes also have chronic kidney disease, and for people with type 2 diabetes, CKD can raise the risk of cardiovascular problems and death ^[1]. Novo Nordisk says the new indication makes Ozempic the most broadly indicated GLP-1 receptor agonist in its class; the announcement does not report any head-to-head comparison with other GLP-1 medicines ^[1].

One warning already on the label is relevant to this population: nausea, vomiting and diarrhea can cause dehydration, and dehydration may cause kidney problems. The label advises drinking fluids and tells patients to contact a health care provider if those symptoms do not go away ^[1]. The company also states that its semaglutide products have different indications, dosages and delivery forms, are not interchangeable, and should not be used outside their approved indications ^[1].

Several practical questions are not addressed in the announcement. It does not say whether insurance coverage or prior authorization requirements will change, or whether the list price will change, and no timeline for those decisions has been reported. Whether other GLP-1 medicines will seek the same kidney indication has likewise not been reported.