FDA Approves Ozempic to Reduce Kidney Disease in Type 2 Diabetes

The FDA has approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).

Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.

“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,” Richard E. Pratley, M.D., medical director at the AdventHealth Diabetes Institute in Orlando, said in a news release.

Th FDA approval is based on results from the FLOW phase 3b kidney outcomes trial investigating the effects of once-weekly Ozempic 1 mg injection on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.

The FLOW trial achieved its primary endpoint with Ozempic, with a 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared with placebo, when added to standard of care.

Adverse events leading to permanent discontinuation were more common in the semaglutide group than in the placebo group and this was mainly because of gastrointestinal events. Serious adverse events were reported in fewer participants in the semaglutide group than in the placebo group.

Data from the FLOW phase 3b study were presented in June 2024 at the American Diabetes Association and published in The New England Journal of Medicine.

The FDA initially approved Ozempic in 2017 to improve blood sugar in adults with type 2 diabetes. In 2020, Ozempic was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.

Ozempic has a list price of $997.58 for one pen. Patients with commercial insurance may be eligible to received Ozempic for a copay of $25, but Novo Nordisk indicates in its terms it may limit the assistance if patients are subject to accumulator adjustment or copay maximizer programs.

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