Ozempic is first GLP-1 drug FDA-approved for kidney disease
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Novo Nordisk's GLP-1 agonist Ozempic has become the first drug in the class to be approved by the FDA to reduce the risk of worsening kidney disease in people with type 2 diabetes.
The approval gives Ozempic (semaglutide) the broadest label in the class, coming after earlier approvals for type 2 diabetes itself and cardiovascular risk reduction in diabetics with known heart disease. Now, the drug is also indicated to prevent kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).
"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," remarked Anna Windle, head of clinical development, medical, and regulatory affairs at Novo Nordisk.
CKD affects approximately 37 million adults in the US and is a common complication of diabetes, with approximately 40% of people with type 2 going on to develop the condition.
The new label for Ozempic is based on the results of the FLOW trial, which showed a statistically significant reduction in kidney disease progression, as well as cardiovascular and kidney death with a 1 mg/kg weekly dose of the injectable drug compared to placebo. That is the same dose of the drug used in the formulation of Ozempic used for the maintenance treatment of diabetes.
In the study, there was a statistically significant 24% relative risk reduction in the combined endpoint of kidney disease worsening, kidney failure, and death due to cardiovascular disease compared to placebo after three years, when added to standard of care. The absolute risk reduction at that time point was 4.9%.
The new indication could give Novo Nordisk a boost against rivals in the GLP-1 agonist class, including Eli Lilly, whose dual GIP/GLP-1 agonist Mounjaro (tirzepatide) competes in the diabetes category and is in a phase 3 trial (TREASURE-CKD) looking at a CKD indication in people with obesity, with and without diabetes.
The two drugs are also competing head to head in obesity, where Novo Nordisk sells its drug as Wegovy and Lilly's is called Zepbound.
Ozempic made global sales of DKK 86.5 billion (over $12 billion) in the first nine months of 2024, while Lilly reported that Mounjaro made around $8 billion in the same period.
Novo Nordisk is also looking to extend the indications for semaglutide even further, with trials on the go in metabolic dysfunction-associated steatohepatitis (MASH) and Alzheimer's disease.