FDA adds a kidney indication to Ozempic based on FLOW

The U.S. Food and Drug Administration has approved Ozempic (semaglutide) injection to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death from cardiovascular disease in adults who have type 2 diabetes and chronic kidney disease (CKD), Novo Nordisk announced on January 28, 2025 ^[1]. The company says the decision makes Ozempic the only GLP-1 receptor agonist with a kidney outcomes indication, and the most broadly indicated drug in its class ^[1].

The approval rests on the FLOW phase 3b kidney outcomes trial, which tested once-weekly semaglutide 1 mg against placebo on top of standard care ^[1]. FLOW enrolled 3,533 adults with type 2 diabetes and CKD — 1,767 assigned to Ozempic and 1,766 to placebo — across roughly 400 investigator sites in 28 countries, starting in 2019 ^[1].

What the trial measured

FLOW's primary endpoint was a composite: a sustained drop in eGFR of 50% or more, a sustained eGFR below 15 mL/min/1.73 m², chronic renal replacement therapy (such as dialysis or transplant), death from kidney causes, and death from cardiovascular causes ^[1]. eGFR is a blood-test-based estimate of how well the kidneys filter waste; lower numbers mean worse function.

The trial met that endpoint with the 1 mg dose, showing a 24% relative risk reduction compared with placebo, which Novo Nordisk describes as a 4.9% absolute risk reduction at three years ^[1]. The study was stopped early on the recommendation of an Independent Data Monitoring Committee after it met pre-specified efficacy criteria, with a median follow-up of 3.4 years ^[1].

It is worth being precise about the dose: FLOW studied Ozempic 1 mg ^[1]. The label covers Ozempic injection at 0.5 mg, 1 mg, or 2 mg ^[1]. The press release does not report results for other doses, and it does not break out how much of the benefit came from kidney events versus cardiovascular deaths. Those details are not in this source.

How common the problem is

CKD affects about 37 million U.S. adults and is expected to grow as the population ages and diabetes becomes more common; diabetes is the leading cause of CKD and kidney failure ^[1]. Roughly 40% of people with type 2 diabetes also have CKD ^[1]. Having both conditions raises the risk of cardiovascular problems and death ^[1].

This is Ozempic's third indication. The FDA first approved it in 2017 to improve blood sugar, along with diet and exercise, in adults with type 2 diabetes ^[1]. In 2020 it added 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]. The kidney indication is the newest addition ^[1].

Why it matters for patients

An FDA-approved indication is not just marketing language. It is the formal statement of what a drug is proven to do, and insurers often lean on it when deciding what to cover and for whom. For adults who have both type 2 diabetes and CKD, this approval gives prescribers a labeled reason to consider semaglutide beyond blood sugar control.

The numbers give a sense of scale. A 24% relative reduction sounds large, but the absolute difference was 4.9 percentage points over three years ^[1]. Both framings describe the same result; the absolute figure is usually the more useful one for thinking about individual benefit.

The indication is specific. It applies to adults with type 2 diabetes and CKD ^[1]. It does not extend to Wegovy or Rybelsus, which are different semaglutide products with their own indications and dosing. Novo Nordisk states that its semaglutide medicines "are not interchangeable and should not be used outside of their approved indications" ^[1]. It is also not known whether Ozempic is safe and effective in children ^[1].

Side effects are unchanged by the new indication. The most common are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1]. Serious risks on the label include pancreatitis, gallbladder problems, vision changes, low blood sugar (especially when combined with insulin or a sulfonylurea), severe stomach problems, serious allergic reactions, and the risk of food or liquid entering the lungs during anesthesia ^[1]. Notably for this population, dehydration from diarrhea, nausea or vomiting can itself cause kidney problems ^[1]. The drug carries a boxed warning about thyroid tumors seen in rodents and is not for people with a personal or family history of medullary thyroid carcinoma or MEN 2 ^[1].

What happens next

The approval is effective now, so the updated indication should appear in prescribing information and in insurer policy reviews. Pricing, coverage changes and supply are not addressed in the announcement and remain unknown from this source.