A weight loss drug has been approved to treat heart disease in overweight and obese patients by Australia’s medicines regulator, in what experts say is a “new frontier for the drugs”.
The Therapeutic Goods Administration (TGA) granted approval in December 2024 for semaglutide 2.4 mg, sold under the brand name Wegovy, to be used as a complementary therapy for adults with both cardiovascular disease and high body mass index, to reduce the related risk of heart attack, stroke or death.
While the new “indication” for the drug meant the TGA had satisfactory evidence of its benefits in regard to those particular conditions, it did not alter the cost of the drug – the decision for the government to subsidise its price and list it on the Pharmaceutical Benefits Scheme (PBS) is separate.
Wegovy is part of the same class of drugs as Ozempic and Mounjaro, known as GLP-1 RAs, which mimic the hormone that stimulates the digestive system, essentially telling the body it is full after eating.
Ozempic has been approved for use in Australia for management of type 2 diabetes, and approved on the PBS for that condition – but not put on the PBS for weight loss. Wegovy was approved by the TGA in August 2024 as a treatment for chronic weight management – but denied for the PBS.
Wegovy’s approval as a prescription for cardiovascular disease followed findings from the Select trial, of 17,604 participants across 41 countries including Australia. They were all above 45 years of age with pre-existing heart disease and a body mass index of 27 or greater, but did not have diabetes.
Half were given Wegovy and the other half a placebo. The results, published in the New England Journal of Medicine, showed that compared with the placebo group, heart attack or stroke incidence among patients taking Wegovy reduced by 20%.
Prof Stephen Nicholls, the lead of the Australian arm of the Select trial and the director of the Victorian Heart Institute at Monash University, said while the GLP-1 RAs medications were originally developed as diabetes drugs, the Select study excluding diabetic patients showed “a new frontier for the drugs in their own right”.
Nicholls called the TGA approval a “significant result”.
“We have really good medications for cholesterol, blood pressure, diabetes, but we’ve never been able to show that a medication that loses weight, or even a medication that we’re using specifically for people who are overweight, can actually reduce the chance of having a heart attack or a stroke,” he said.
The study did not directly link the benefits of Wegovy for patients with heart disease to how much weight was lost; even patients who did not lose a lot of weight found the drugs positively impacted inflammation, blood lipids and blood pressure, all crucial in preventing heart attacks and strokes, Nicholls said.
“There’s potentially a lot of people who might benefit from these therapies, and so we need better access,” Nicholls said, pointing to the need to improve availability and lower the cost for patients.
Dr David Henry, an honorary adjunct professor in the faculty of science and medicine at Bond University, said the Select trial was strong.
Whether Wegovy should get PBS listing for the new indication was a “more difficult question”, he said.
With a “large population” likely to be now eligible to be prescribed Wegovy under the new indication, he noted “the budgetary effect [of putting it on the PBS] will be huge”.
