Novo Nordisk’s GLP-1 agonist Ozempic has shown efficacy in yet another indication, achieving a 24% reduction in kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD) in the FLOW trial.
The data – which was first signposted by the Danish drugmaker last October – showed a statistically significant reduction in the primary endpoint, a composite of kidney disease progression, major adverse cardiovascular events (MACE) and death with a 1 mg/kg weekly dose of the injectable drug.
That is the typical maintenance dose for Novo Nordisk’s Ozempic (semaglutide), used to treat type 2 diabetes. Semaglutide is also used to treat obesity under the Wegovy brand at a typical 2.4 mg weekly dose.
The FLOW data will be used to file for an extension to the Ozempic label in the US and EU before the end of this year, said the company, which points out that around 40% of people with type 2 diabetes have CKD. Semaglutide has the potential to become the first GLP-1 treatment option for these patients, it added.
FLOW is the latest major outcomes study to show the added benefit of semaglutide on hard clinical endpoints as well as its proven effects on blood sugar and weight loss.
It comes after the SELECT trial of Wegovy showed a 20% reduction in cardiovascular outcomes when used in overweight or obese patients who had underlying cardiovascular disease, but no prior history of diabetes, and the STEP-HFpEF study which showed Wegovy was able to reduce symptoms and improve exercise capacity in overweight people with heart failure.
The outcomes data could also help Novo Nordisk stay ahead of rivals in the GLP-1 category, including Eli Lilly with dual GLP-1/GIP agonist tirzepatide, now approved as Mounjaro for diabetes and Zepbound for obesity. Tirzepatide has not yet been shown to reduce cardiovascular risk, but studies are underway, albeit with results not due for a couple of years at least.
In January, Novo Nordisk reported that sales of Ozempic had risen 60% to $14 billion in 2023, while Wegovy rocketed more than 400% to $4.5 billion, driven by huge demand that it has been struggling to meet. The following month, it moved to address those supply issues in a three-way agreement that would see it acquire a trio of manufacturing facilities from Catalent.
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