Novo Nordisk's (NVO.US) updated label for semaglutide supported by positive data from the FLOW renal outcomes trial

Novo Nordisk (NVO.US) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the updated label for Ozempic (semaglutide) to include information on the risk reduction of kidney disease-related events, based on the positive data from the FLOW renal outcomes trial. According to the press release, Ozempic could become the first GLP-1 receptor agonist to potentially reduce the risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease (CKD). Novo Nordisk has also submitted a similar label expansion application to the U.S. FDA, which is expected to receive a review decision in the first half of 2025.

The FLOW clinical trial was a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of once-weekly subcutaneous injection of 1.0mg Ozempic as an add-on therapy to standard care in preventing the progression of kidney injury in patients with CKD and type 2 diabetes, as well as the risk of kidney and cardiovascular death, including a sustained decrease in estimated glomerular filtration rate (eGFR) ≥50%, sustained eGFR <15 ml/min/1.73 m, initiation of chronic kidney replacement therapy, kidney disease-related death, or cardiovascular-related death. The trial recruited 3,533 patients with CKD and type 2 diabetes.

In the FLOW trial, Ozempic significantly reduced the combined risk of kidney disease progression, cardiovascular, and kidney disease-related death by 24% compared to placebo. In addition, the secondary endpoints showed an 18% reduction in the risk of major cardiovascular events and a 20% reduction in the risk of death from any cause. The detailed results of the trial were published in the May issue of the New England Journal of Medicine.