Novo Nordisk’s semaglutide cut the risk of major cardiovascular events and death from multiple causes in a Phase 3 study involving patients with type 2 diabetes and chronic kidney disease, building the company’s case for expanding the drug in a broad range of indications.
The data, which captured secondary endpoints of the FLOW study, were presented Friday at the European Renal Association’s conference and published in the New England Journal of Medicine.
Earlier this year, Novo touted topline results and a win in the primary endpoint of that trial: Semaglutide reduced the risk of kidney disease progression as well as cardiovascular and kidney death by 24% versus placebo. The trial was stopped early for efficacy.
Novo plans to file for a label expansion of the GLP-1 agonist, marketed as Wegovy for weight loss and Ozempic for diabetes, in the US and EU this year.
Thursday’s data showed that the risk of major cardiovascular events was 18% lower in the semaglutide group compared to placebo, and the risk of death from any cause was 20% lower for patients on semaglutide. The mean annual slope of eGFR levels also reflected a slower decrease in semaglutide patients than those on placebo, meaning a lower rate of kidney function decline.
Michael RadinMichael Radin, Novo’s executive medical director, told Endpoints News that the FLOW trial is the first dedicated renal outcome study with a GLP-1. Each one of the secondary endpoints met statistical significance, he added.
These data add to results from the SELECT trial, where the drug was shown to cut major cardiovascular risks by 20% in patients who were overweight or obese and with existing cardiovascular issues.
When asked about the significance of the FLOW data, Radin said that 20 patients would need to be treated over three years to prevent one renal event, “and that’s considered really good in terms of a therapy, so while putting that question into context, I think when you look at absolute risk reduction, you look at the number needed to treat. That’s what’s really powerful about the data.”
The event rate in the placebo arm was 23.5% versus 18.7% in the semaglutide arm, he said, translating to an absolute risk reduction of 4.5%.
The NEJM article noted that 45 patients would have to be treated over three years to prevent one major cardiovascular event, and 39 patients would have to be treated to prevent one death from any cause.
As for what these data mean for semaglutide, Radin added that the drug now has the “unique space” of having data showing the slowing of risk of worsening kidney disease, in addition to “the existing huge evidence” for the drug’s glycemic efficacy and cardiovascular risk reduction benefits.