Novo Nordisk Highlights Ozempic® Benefits For Chronic Kidney Disease Patients

Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the label for Ozempic®  (once-weekly subcutaneous semaglutide). This opinion is based on findings from the FLOW kidney outcomes trial. 

This trial evaluated the impact of Ozempic® on reducing risks associated with chronic kidney disease (CKD) in adults with type 2 diabetes, along with a persistent decline in estimated glomerular filtration rate (eGFR), initiation of kidney replacement therapy and kidney or cardiovascular-related death.

Martin Holst Lange, executive vice president for Development at Novo Nordisk, said in a statement, “Approximately 40% of people with type 2 diabetes develop chronic kidney disease, and there is a need for treatments that can help to reduce kidney disease progression. With this positive opinion, Ozempic® will become the first and only GLP-1 receptor agonist to show lowering of risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease."

The FLOW trial results showed that semaglutide 1.0 mg significantly reduced the risk of kidney disease progression and cardiovascular or kidney death by 24% compared to placebo. Additionally, secondary analyses revealed an 18% reduction in major cardiovascular events and a 20% reduction in all-cause mortality.