Novo Nordisk’s latest results from its semaglutide studies in chronic kidney disease (CKD) have set a new standard for comprehensive diabetes care, according to the company’s executive medical director, Michael Radin, M.D. The findings, which were fully unveiled early Friday, are reshaping expectations for the treatment’s impact on major kidney and cardiovascular outcomes in patients with Type 2 diabetes who also suffer from CKD.
During the 61st meeting of the European Renal Association, detailed results from the FLOW trial were shared. These results were simultaneously published in The New England Journal of Medicine. The trial assessed the impact of once-weekly semaglutide 1.0 mg on serious kidney complications such as kidney failure, decline in kidney function, and death from kidney or cardiovascular causes.
The latest data indicate that semaglutide significantly reduces the risk of major cardiovascular events by 18% and decreases all-cause mortality by 20%. Importantly, the progression of kidney function decline was notably slower in the semaglutide group compared to placebo, as measured by the estimated glomerular filtration rate—a critical marker of kidney health.
Novo’s decision to halt the FLOW trial prematurely in October due to a positive efficacy signal has proven prescient, with these comprehensive results confirming semaglutide’s potent benefits. “These results really move the needle,” Radin emphasized, pointing to the necessity of holistic treatment approaches for patients grappling with multiple chronic conditions like Type 2 diabetes and CKD.
Over 800 million people globally suffer from CKD, with approximately 40% of those with Type 2 diabetes also affected. These individuals are at a higher risk of requiring dialysis and are more susceptible to cardiovascular mortality. Radin highlighted the unique position of semaglutide in addressing these complex patient needs compared to other treatments like Bayer’s Kerendia, RAS inhibitors, and SGLT2 inhibitors, which have their limitations.
The safety profile of semaglutide reported in the FLOW study aligns with previous clinical findings. However, the trial did note a higher discontinuation rate among the semaglutide group due to gastrointestinal issues—a common side effect across the GLP-1 drug class.
Looking forward, Novo Nordisk has ambitious plans to expand semaglutide’s label to include treatment for kidney disease, with regulatory filings in the U.S. and Europe anticipated by the end of 2024. Beyond CKD, semaglutide’s potential is being explored in other conditions, including peripheral arterial disease and liver health issues such as fibrosis in patients with fatty liver disease and steatohepatitis.
Additionally, the drug’s scope is extending into neurological conditions, with ongoing trials evaluating its efficacy in early Alzheimer’s disease among populations with and without diabetes.
Semaglutide is already approved as Ozempic for Type 2 diabetes and as Wegovy for obesity management, with both forms approved for reducing cardiovascular risk. The oral version, Rybelsus, is also available for diabetes management. These expanded applications of semaglutide underscore its potential to significantly impact a broad spectrum of diseases, affirming its role as a cornerstone in modern therapeutic regimens.
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