European News. EMA, positive on reduction Kidney disease for LABEL EXTENSION
$Novo-Nordisk A/S (NVO.US)$ European Medicines Agency (EMA) has adopted a positive opinion for an update of the label of Ozempic ® (once-weekly subcutaneous semaglutide) to reflect data from the FLOW trial on renal outcomes.
FLOW trial evaluated the risk reduction associated with treatment with Ozempic ® in chronic kidney disease-related events in adults with type 2 diabetes and chronic kidney disease (CKD). FLOW, semaglutide 1.0 mg demonstrated a statistically significant and greater 24% reduction in the risk of kidney disease progression as well as cardiovascular and renal death compared to placebo.
Additionally, the secondary endpoints of the trial showed that the risk of major cardiovascular events was reduced by 18% and the risk of all-cause mortality was reduced by 20%.' About 40% of people with type 2 diabetes develop chronic kidney disease. "There is therefore a need for treatments that can help slow the progression of kidney disease," said Martin Holst Lange, executive vice president of development at Novo Nordisk.
With this positive review, Ozempic ® will become the first and only GLP-1 receptor agonist to show a decreased risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease.
'Novo Nordisk has also filed for a label extension in the United States, and a decision is expected in the first half of 2025'
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