Ozempic ‘saving kidneys, hearts and lives’ as TGA backs new indication

The Therapeutic Goods Administration (TGA) has granted a label expansion for Novo Nordisk’s GLP-1 receptor agonist, Ozempic (semaglutide), to reduce the risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease (CKD).

Diabetes remains the leading cause of CKD nationally, accounting for 38% of new cases. An estimated 330,000 Australians live with both conditions, with approximately 10,000 projected to develop kidney failure requiring dialysis or transplantation.

Professor Vlado Perkovic, nephrologist and Provost at UNSW, said “Chronic kidney disease is a major health issue in Australia and is a serious and progressive complication of type 2 diabetes. If not managed appropriately and in serious cases, it may lead to kidney failure, heart disease and stroke, and in some cases, premature death.”

The regulatory approval is based on data from the FLOW trial, led by Professor Perkovic, which showed Ozempic reduced the risk of major kidney events by 24% and cardiovascular events by 18% in people with type 2 diabetes and CKD. The study also reported a 20% reduction in all-cause mortality among Ozempic-treated patients.

“We would be saving kidneys, hearts and lives in this population by making this drug available to them and that’s quite extraordinary for one treatment to be able to do,” Professor Perkovic noted when the trial was published.

Dr Ana Svensson, Vice President of Clinical, Medical and Regulatory at Novo Nordisk Oceania, stated, “This approval represents a step forward in addressing the multifaceted needs of individuals living with type 2 diabetes and chronic kidney disease.”

Professor Perkovic further emphasised, “Early intervention can help with slowing disease progression. I encourage people living with type 2 diabetes to speak with their healthcare providers about kidney health. We need to continue raising awareness and the importance of early CKD detection.”

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