According to Zhitong Financial APP, Novo-Nordisk A/S (NVO.US) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on updating the label of its blockbuster therapy Ozempic (semaglutide) to include information on reducing the risk of renal-related events, based on 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 progression of renal disease in adult patients with type 2 diabetes and chronic kidney disease (CKD). Novo-Nordisk has also submitted a similar label expansion application to the FDA in the USA, expecting to receive review results in the first half of 2025.

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

In the FLOW trial, Ozempic significantly reduced the comprehensive risk of progression of renal disease, cardiovascular, and renal disease-related mortality by 24% compared to placebo. In addition, the trial's secondary endpoints showed that 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 May of this year in the New England Journal of Medicine.