On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.
This follows the positive recommendation for PBS listing of Ozempic® for type 2 diabetes mellitus by Australia’s PBAC in December 2024. Earlier the same month, the EMA’s CHMP had adopted a positive opinion for an update of the Ozempic® label to reflect data from the FLOW kidney outcomes trial which assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events.
In September 2024, Australia’s TGA accepted Novo Nordisk’s application for Ozempic® for reducing the risk of kidney failure.