Wegovy approved for cutting cardiovascular disease risk

The Therapeutic Goods Administration (TGA) has approved semaglutide (sold as Wegovy) to treat cardiovascular disease in overweight and obese patients, but GPs have raised concerns that cost barriers remain.
 
As of 19 December 2024, changes to its indication mean the treatment can be used for the reduction in risk of major adverse cardiovascular events.
 
‘Wegovy is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a body mass index (BMI) ≥27kg/m2, and without established type 1 or type 2 diabetes,’ the TGA says.
 
While Chair of RACGP Specific Interests Obesity Management, GP and dietitian Dr Terri-Lynne South, welcomed the change, she remains concerned about the medication’s cost.
 
‘It’s still extremely expensive and so it’s a matter of access and equity,’ she told newsGP.
 
‘I’m hoping that with more options, there’ll be a competitive price market so that we can actually see that the people who need these medications most have equitable access and affordable care.
 
‘I think that we will see more and more indications for GLP-1 medications, separate from an obesity management point of view, and I think it just shows you how wide-ranging the GLP-1 receptors are.’
 
The change comes after the SELECT trial, an international study of more than 17,000 participants across 41 countries, found Wegovy reduced cardiovascular events by 20% in people with pre-existing heart disease who were overweight or obese but did not have diabetes.
 
Professor Stephen Nicholls, who led the Australian tranche of the trial and is the Director of the Victorian Heart Institute at Monash University, said the medication’s approval highlights the ‘critical role of overweight and obesity as major drivers of heart disease’.
 
He said this is on par with cholesterol, blood pressure, diabetes and smoking and reinforces that these risks can be actively reduced with targeted therapies.

‘The SELECT trial demonstrated that the cardiovascular benefits of semaglutide extend beyond weight loss … this is a groundbreaking result for patients,’ Professor Nicholls said.
 
‘This drug also positively impacts inflammation, blood lipids and blood pressure, which are all crucial in preventing heart attacks and strokes.

‘What this tells us is that if you have heart disease and are overweight or obese, not only are you at a higher risk of another cardiovascular event, but that risk can now be significantly reduced.’
 
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, said the ‘promising results’ add further evidence for the use of semaglutide as an adjunct to clinical weight management, especially in those overweight and obese people.
 
‘This must be in addition to standard approaches of lipid and blood pressure management with lifestyle changes,’ he told newsGP.
 
‘It would assist patient outcomes if these agents were available at more affordable pricing, notably because often those most likely to benefit have disadvantages socially and economically.’
 
Wegovy became available in Australia in August last year, with the semaglutide drug specifically targeted for weight loss.
 
It was initially indicated for chronic weight management for those living with obesity or who are overweight with at least one weight-related comorbidity, such as high blood pressure, type 2 diabetes, or high cholesterol.
 
While its introduction into the Australian market was welcomed by GPs, some scepticism remained amid chronic worldwide shortages of similar medications.
 
Wegovy’s expansion comes at a time when another semaglutide medication, Ozempic, is set to remain in shortage for the entirety of 2025 due to ‘an unexpected increase in consumer demand’.
 
Dr South said the new indication can also help GPs and patients alike to think about obesity not just in terms of BMI or weight.
 
‘We’re starting to see that it’s associated with other health conditions which can have a significant clinical impact on cardiovascular events for people who are living in a larger body, not just about weight loss,’ she said.
 
‘We can talk to patients around the reason that they might want to take a medication to reduce their risk of a further additional cardiovascular event, as opposed to a conversation about weight loss.
 
‘It’ll be a conversation GPs are having about, “hey, there’s a new medication that can reduce your risk of developing another heart event” and talking to people around that.’
 
Wegovy’s manufacturer Novo Nordisk has had several attempts to have the medication added to the Pharmaceutical Benefits Scheme for severe obesity rejected by the Pharmaceutical Benefits Advisory Committee.
 
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