Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec

While it’s hard to overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latest deep dive into semaglutide data in chronic kidney disease (CKD) could help set a new standard for “holistic” care for many diabetes patients, the company’s executive medical director, Michael Radin, M.D., told Fierce Pharma.

Early Friday, Novo shared full results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and CKD.

Of note in the latest data drop, semaglutide helped slash the risk of major cardiovascular events by 18% and reduced the risk of all-cause mortality by 20%. Further, the rate of kidney function decline over time was “significantly slower” with semaglutide versus placebo, as tracked by estimated glomerular filtration rate—a common measure of kidney function—Radin said.

Novo presented its detailed look at the FLOW results at the 61st meeting of the European Renal Association. The data were also published Friday in The New England Journal of Medicine.

The full results come after Novo shared headline data in March that found semaglutide reduced the risk of kidney disease progression and kidney and cardiovascular death by 24%. Back in October, the company halted its FLOW trial early thanks to a positive efficacy signal.

While semaglutide has already enjoyed ample popularity and uptake, “I do believe that these results really move the needle,” Radin said.

“In other words, Type 2 diabetes doesn’t exist in a vacuum: These patients often have concomitant cardiovascular disease, they have chronic kidney disease, and there’s a move in the medical community to be able to treat these patients holistically,” he explained.

CKD affects more than 800 million people worldwide, according to Novo Nordisk. Some 40% of patients with Type 2 diabetes also have CKD, many of whom will eventually require dialysis, Radin noted. Those patients are also more likely to die of cardiovascular death.

In Radin’s eyes, the FLOW data make "semaglutide stand out uniquely amongst the options that are available for patients with type 2 diabetes and chronic kidney disease.”

The medical director pointed to other pillars of care for CKD, including Bayer’s Kerendia (finerenone), RAS inhibitors and SGLT2 inhibitors, which each come with shortcomings. Kerendia and RAS drugs can't help with glycemic control, Radin said, whereas SGLT2 inhibitors’ glycemic efficacy wanes as kidney function worsens.

Safety results in FLOW were on par with semaglutide’s known profile in other clinical trials, Radin said. The Novo exec noted that “significantly fewer” patients in the trial’s semaglutide group experienced a serious adverse event versus the control arm. However, more patients on semaglutide discontinued therapy compared to placebo, driven by gastrointestinal disorders, which is consistent with the GLP-1 class as a whole, Radin noted.

Back in March, when Novo unveiled its headline data in CKD, the company said it would file for regulatory approvals in the U.S. and Europe this year to expand semaglutide’s label. While Radin was unable to provide an update on that front, he confirmed that Novo is sticking by its plan to seek updated approvals in kidney disease by the end of 2024.

Elsewhere, Novo is far from done with its semaglutide development journey. The company currently has a functional trial underway in patients with Type 2 diabetes who have peripheral arterial disease with symptomatic claudication, which is set to read out at the end of the year, Radin said.

In terms of liver health, Novo is also assessing semaglutide’s potential ability to help with fibrosis in patients with fatty liver disease and steatohepatitis in a phase 3 trial.

The company is testing oral semaglutide for its ability to help people with early Alzheimer’s disease as well. Novo currently has two trials underway in that space—evoke and evoke+—which are assessing semaglutide in diabetes and non-diabetes Alzheimer’s populations. 

Semaglutide is currently approved in its injectable form as Ozempic for Type 2 diabetes and as Wegovy in obesity. Both medicines also boast nods for cardiovascular risk reduction. There's also an oral form of the drug called Rybelsus for diabetes.