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Thursday, December 12, 2024

Novo EU Ozempic® label to reflect risk reduction of kidney disease-related events

 Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events, including persistent ≥50% decline in estimated glomerular filtration rate (eGFR), onset of persistent eGFR <15 ml/min/1.73 m2, initiation of chronic kidney replacement therapy, kidney death or cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD).

https://finance.yahoo.com/news/novo-nordisk-european-regulatory-authority-134700123.html

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