Australia’s medicines regulator has approved a weight loss drug to treat heart disease in overweight and obese patients, marking a significant development, according to experts.
In December 2024, the Therapeutic Goods Administration (TGA) approved semaglutide 2.4 mg, branded as Wegovy, as a complementary therapy for adults with both cardiovascular disease and a high body mass index (BMI). The drug is intended to help reduce the risk of heart attack, stroke, and death in these patients.
While the TGA has granted approval for this specific use of the drug, it does not affect its cost. The decision to subsidize Wegovy on the Pharmaceutical Benefits Scheme (PBS) is still pending.
Wegovy belongs to the same class of drugs as Ozempic and Mounjaro, known as GLP-1 receptor agonists (GLP-1 RAs). These drugs mimic a hormone that signals to the body that it is full after eating.
Ozempic is approved for managing type 2 diabetes in Australia and is listed on the PBS for that condition. However, it is not covered by the PBS for weight loss. Wegovy, approved by the TGA in August 2024 for chronic weight management, was also denied PBS listing for that purpose.
The TGA’s approval for Wegovy to treat cardiovascular disease is based on findings from the Select trial, which involved 17,604 participants from 41 countries, including Australia. The participants were over 45 years old, had pre-existing heart disease, and had a BMI of 27 or higher, but did not have diabetes.
The trial split participants into two groups—one received Wegovy, and the other a placebo. Results published in the New England Journal of Medicine showed that those taking Wegovy had a 20% lower incidence of heart attacks or strokes compared to the placebo group.
Professor Stephen Nicholls, who led the Australian arm of the trial and is the director of the Victorian Heart Institute at Monash University, called the approval a “significant result.” He highlighted that while GLP-1 RAs were originally developed for diabetes management, the Select trial showed that these drugs could benefit patients without diabetes, opening a new avenue for treatment.
“We’ve always had good medications for cholesterol, blood pressure, and diabetes, but we’ve never had a drug specifically for weight loss that could also reduce the risk of heart attacks or strokes,” Nicholls said.
The trial did not directly link the benefits of Wegovy to weight loss. Even patients who didn’t lose significant weight experienced improvements in inflammation, blood lipids, and blood pressure—factors that play a key role in preventing heart attacks and strokes.
Nicholls emphasized the need for better access to these therapies and called for improved availability and lower costs for patients who could benefit from them.
Dr. David Henry, an honorary adjunct professor at Bond University, praised the strength of the Select trial but noted that determining whether Wegovy should be listed on the PBS for its new indication was a complex issue.
He pointed out that with a large number of patients now eligible for the drug under this new approval, including it on the PBS could have a significant budgetary impact.
