Novo Nordisk today announced it has notched another win for its GLP-1 agonist semaglutide (Ozempic), this time for reducing cardiovascular disease and slowing kidney disease in diabetic patients. The latest results from the FLOW trial suggest the drug cuts risk of death in this population by as much as 24%.
The drug’s sales have already reached almost $15B per year. Semaglutide is currently approved to improve glycemic control in adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the U.S. and E.U. in 2024.
“Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease,” said Martin Holst Lange, MD, PhD, executive vice president for development at Novo Nordisk.
The FLOW trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of the progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD). The trial enrolled several thousand people with the two conditions.
The trial achieved its primary endpoint, demonstrating a superior reduction in kidney disease progression, major adverse cardiovascular events (MACE), and by lowering risk of death by 24% for people. In fact, the trial was stopped early because the drug’s benefits were so clear.
The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction.
In the trial, semaglutide 1.0 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 1.0 mg trials. The detailed results from FLOW will be presented at an upcoming scientific conference.
FLOW was a randomized, double-blind, parallel-group, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care on kidney outcomes for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD. 3,533 people were enrolled in the trial conducted in 28 countries at around 400 investigator sites. The FLOW trial was initiated in 2019.
The key objective of FLOW has been to demonstrate delay in progression of CKD and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease, or death from cardiovascular disease.
