Ozempic cleared for kidney disease treatment

News

The Therapeutic Goods Administration (TGA) has approved semaglutide, sold as Ozempic, for reducing the risk of kidney disease progression in patients with type 2 diabetes and chronic kidney disease.

 

The expansion allows the drug to be used as an ‘adjunct to standard of care therapy to reduce the risk of sustained decline of kidney function and to reduce the risk of cardiovascular death in adults with type 2 diabetes and chronic kidney disease’.

 

Until now, Ozempic was only approved in Australia for the treatment of type 2 diabetes, despite its off-label popularity as a weight-loss drug.

 

The expansion comes as significant shortages of the medication have now been resolved, with Ozempic taken off the TGA’s medication shortages list as of 18 July.

 

Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, welcomes the change but continues to advocate for greater accessibility of the medication on the Pharmaceutical Benefits Scheme (PBS), such as for people with chronic kidney disease but no diabetes diagnosis.

 

‘It’s great to see the expansion, but it may not necessarily change patients’ access under the PBS. So, for GPs, it’s good to know, but may not change GP prescribing habits at this stage,’ he told newsGP.

 

‘[Semaglutide] in the international guidelines is a suggested additional therapy for the management of chronic kidney disease.

 

‘However, despite being in the evidence-based guidelines, the PBS is not currently supportive of that, according to the funding arrangements.’

 

The RACGP has also called for semaglutide to be included on the PBS for weight loss, with the medication currently only on the scheme for treatment of type 2 diabetes.

 

With the high cost of Ozempic placing it out of reach for many, Dr Deed said many people with chronic kidney disease ‘suffer from disadvantage, both in health and economics’.

 

Aboriginal and Torres Strait Islander people are twice as likely to develop kidney disease and four times as likely to die from kidney disease than non-indigenous Australians, according to Kidney Health Australia.

 

Diabetes is currently the leading cause of chronic kidney disease in Australia, responsible for 38% of all new cases.

 

Around 1.2 million people in Australia are diagnosed with type 2 diabetes and of those, 330,000 people also have chronic kidney disease.

 

The TGA’s expansion follows a 2024 clinical trial which found semaglutide reduces the risk of major kidney events in type 2 diabetes patients by 24%.

 

Dr Ana Svensson, Vice President of Clinical, Medical and Regulatory at Novo Nordisk Oceania, said the manufacturer is committed to ‘expanding access to innovative therapies’.

 

‘This approval represents a step forward in addressing the multifaceted needs of individuals living with type 2 diabetes and chronic kidney disease,’ she said.

 

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