Novo Nordisk Receives Positive CHMP Opinion for Ozempic Label Update Based on FLOW Trial Data

Novo Nordisk (NVO.US) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the label of its blockbuster therapy Ozempic (semaglutide) to include information on reducing the risk of kidney-related events. This decision is based on the positive data from the FLOW renal outcomes trial.According to the press release，Ozempic May Become the First GLP-1 Receptor Agonist to 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, with the review result expected in the first half of 2025.

FLOW Clinical Trial is a randomized, double-blind, placebo-controlled clinical trial designed to examine the effects of once-weekly subcutaneous injections of 1.0 mg Ozempic compared with placebo as an adjunct to standard care in preventing the progression of kidney damage and the risk of renal and cardiovascular death in patients with CKD and type 2 diabetes. These events include a sustained decline in estimated glomerular filtration rate (eGFR) of ≥50%, a sustained eGFR below 15 ml/min/1.73 m², initiation of chronic renal replacement therapy, kidney-related death, or cardiovascular-related death. The trial enrolled 3,533 patients with CKD and type 2 diabetes.

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

Editor: Yu Jian SF069