The Therapeutic Goods Administration (TGA) has approved semaglutide, marketed as Wegovy, as an adjunct to standard therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults. This decision, effective from 19 December 2024, expands the drug’s indications to include the reduction of cardiovascular risks in individuals with established heart disease but without diabetes.
A Groundbreaking Trial
The approval follows the promising results of the SELECT trial, a large-scale international study involving over 17,000 participants across 41 countries. The trial demonstrated that Wegovy can reduce the risk of cardiovascular events by 20% in individuals with pre-existing heart disease who are overweight or obese but do not have diabetes.
Professor Stephen Nicholls, Director of the Victorian Heart Institute at Monash University, led the Australian portion of the SELECT trial. He highlighted the significance of the trial’s findings, stressing the importance of addressing overweight and obesity as key contributors to heart disease, alongside traditional risk factors such as high cholesterol, blood pressure, and smoking.
“The cardiovascular benefits of semaglutide go beyond weight loss,” Professor Nicholls said. “This is a groundbreaking result for patients with heart disease. The drug also positively impacts inflammation, blood lipids, and blood pressure, all of which are crucial in preventing heart attacks and strokes.”
Cost Concerns Persist
Despite the promising results, some medical professionals remain concerned about the cost of the drug. Dr. Terri-Lynne South, Chair of RACGP Specific Interests Obesity Management, welcomed the approval but emphasized that the drug remains prohibitively expensive for many patients.
“It’s still extremely expensive, and this is a matter of access and equity,” Dr. South told newsGP. “I hope that with more competition, the price will become more affordable, allowing equitable access for those who need these medications the most.”
Dr. South also pointed out that the new indication for Wegovy will help GPs and patients approach obesity management from a broader perspective, focusing not only on weight loss but also on reducing the risk of cardiovascular events.
Expanding the Role of GLP-1 Medications
The approval of Wegovy for cardiovascular risk reduction is part of a broader trend in the growing use of GLP-1 receptor agonists like semaglutide. Dr. Gary Deed, Chair of RACGP Specific Interests Diabetes, noted that the drug’s new indication provides further evidence for its role in clinical weight management, particularly in overweight and obese patients.
“While semaglutide can support weight loss, it is crucial that it be used in conjunction with standard approaches for managing lipid levels, blood pressure, and lifestyle changes,” Dr. Deed said. “Patient outcomes would improve if these medications were made more affordable, especially for those who are socially and economically disadvantaged.”
Wegovy’s Market Expansion
Wegovy, which became available in Australia in August 2024, was initially approved for chronic weight management in individuals living with obesity or overweight with at least one weight-related comorbidity. However, the drug’s expansion into the cardiovascular disease market is expected to further elevate its role in medical practice.
The approval comes at a time when demand for another semaglutide product, Ozempic, has led to global shortages. The company behind both drugs, Novo Nordisk, has announced that Ozempic will remain in short supply throughout 2025 due to an unexpected surge in consumer demand.
Looking Ahead
As Wegovy’s indications expand, medical professionals are rethinking how they approach obesity and cardiovascular risk. GPs will now have the option to discuss the medication not just in terms of weight loss, but as a way to help reduce the risk of subsequent cardiovascular events.
“This opens up a new conversation with patients,” Dr. South explained. “Instead of focusing solely on weight loss, we can now talk about reducing the risk of further heart problems, which is a significant shift in how we approach treatment.”
While the TGA’s approval is a significant step forward, access to Wegovy remains a concern. Whether the medication can be added to the Pharmaceutical Benefits Scheme for wider accessibility remains to be seen.
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