FDA Approves Ozempic for Kidney Disease

The Food and Drug Administration has approved Ozempic to reduce the risk of kidney disease and prohibit kidney failure and death from cardiovascular disease in those with kidney disease and type 2 diabetes.

According to the Centers for Disease Control and Prevention (CDC), an estimated 35.5 million adults in the United States have chronic kidney disease (CKD). This represents approximately 14% of the adult population, the CDC reports.

Ozempic’s maker, Novo Nordisk, shared in a press release its excitement over the FDA’s approval: “This approval, along with its existing indications for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events in adults also with known heart disease, establishes Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class.”

Anna Windle, PhD, senior vice president of clinical development, medical & regulatory affairs at Novo Nordisk, said in a statement, “Chronic kidney disease is very serious and common in patients living with type 2 diabetes 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.”

Windle continued, “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.”

The Surprising Results of Ozempic’s Clinical Trial

Ozempic Approved By FDA For Kidney Disease—In Ultra-Popular Drug’s Latest Approvalhttps://t.co/d56wFFk63G pic.twitter.com/F500g78hlC

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A clinical trial was instituted by the FDA that investigated the effects of Ozempic on those who suffer from kidney and cardiovascular disease. The results were quite encouraging, resulting in FDA approval.

Patients participated in a FLOW phase of the medical trial. FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled trial comparing once-weekly Ozempic 1 mg with a placebo.

This trial resulted in 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 to placebo, when added to standard of care.”

Ozempic was first approved by the FDA in 2017 for blood sugar control in type 2 diabetes. It received a cardiovascular indication in 2020 and is now the most broadly indicated GLP-1 drug for managing diabetes, kidney disease, and heart risk.

Semaglutide products Ozempic, Rybelsus, and Wegovy top the list of the drugs selected for Medicare Part D price negotiation, part of the Inflation Reduction Act under former United States President Joe Biden.