Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has approved the weight loss drug Wegovy (semaglutide 2.4 mg) as a treatment for heart disease in overweight and obese patients. Experts are calling it a “new frontier” in weight loss medications.
The TGA’s December 2024 approval allows Wegovy to be prescribed as a complementary therapy for adults with cardiovascular disease and a high body mass index (BMI). The goal is to reduce the risk of heart attack, stroke, and death in these patients.
However, this approval does not impact the drug’s cost. Whether Wegovy will be subsidized under the Pharmaceutical Benefits Scheme (PBS) remains a separate decision.
How Wegovy Works
Wegovy belongs to the GLP-1 receptor agonist (GLP-1 RA) drug class, alongside Ozempic and Mounjaro. These drugs mimic a hormone that regulates digestion, helping people feel full after eating.
While Ozempic is PBS-listed for type 2 diabetes, it is not subsidized for weight loss. Similarly, Wegovy was approved by the TGA in August 2024 for chronic weight management but was denied PBS listing.
Breakthrough Findings in the Select Trial
The approval follows results from the Select trial, which studied 17,604 participants across 41 countries, including Australia. The participants—aged 45+, with pre-existing heart disease and a BMI of 27 or higher but without diabetes—were divided into two groups:
- One received Wegovy
- The other received a placebo
The findings, published in the New England Journal of Medicine, revealed that Wegovy reduced heart attack or stroke risk by 20% compared to the placebo.
Experts Weigh In
Professor Stephen Nicholls, lead researcher of the Australian arm of the trial and director of the Victorian Heart Institute at Monash University, described the approval as a “significant result.”
“We have excellent medications for cholesterol, blood pressure, and diabetes, but we’ve never had a weight loss drug that directly lowers the risk of heart attack or stroke,” Nicholls said.
Interestingly, the study found that Wegovy’s benefits extended beyond weight loss—it also reduced inflammation, improved blood lipids, and lowered blood pressure, all critical for heart health.
Dr. David Henry, an honorary adjunct professor at Bond University, called the Select trial “strong evidence” for the drug’s effectiveness. However, he noted that adding Wegovy to the PBS would have a huge financial impact given the large number of eligible patients.
“There’s potentially a lot of people who might benefit from these therapies, and so we need better access,” Nicholls emphasized.
What’s Next?
With Wegovy now approved for heart disease treatment, attention shifts to whether the government will subsidize it under the PBS—a decision that could determine accessibility and affordability for thousands of Australians.
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