In a landmark decision, the Therapeutic Goods Administration (TGA) has expanded the approval of semaglutide 2.4 mg (Wegovy) to include cardiovascular disease treatment in overweight and obese patients, marking the first such authorization in Australia. This expanded indication positions the medication as a complementary therapy for reducing major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Clinical Evidence from SELECT Trial
The approval is backed by compelling data from the SELECT trial, a large-scale international study that enrolled more than 17,000 participants across 41 countries, including Australia. The trial's results, published in late 2023, revealed that Wegovy reduced cardiovascular events by 20% in overweight or obese individuals with pre-existing heart disease who did not have diabetes.
Comprehensive Cardiovascular Benefits
Professor Stephen Nicholls, who led the Australian arm of the SELECT trial and serves as Director of both the Victorian Heart Hospital and Victorian Heart Institute at Monash University, emphasized the significance of this development. "This approval highlights the critical role of overweight and obesity as major drivers of heart disease—on par with cholesterol, blood pressure, diabetes and smoking," he stated. "It reinforces that these risks can be actively reduced with targeted therapies."
Mechanism of Action and Impact
The drug's benefits extend beyond simple weight reduction, according to Professor Nicholls. "The SELECT trial demonstrated that the cardiovascular benefits of semaglutide extend beyond weight loss. This drug also positively impacts inflammation, blood lipids and blood pressure, which are all crucial in preventing heart attacks and strokes," he explained.
Clinical Implications
For healthcare providers and patients, this approval represents a significant advancement in cardiovascular disease management. "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. This is a groundbreaking result for patients," Professor Nicholls concluded.
The approval marks a pivotal shift in the treatment paradigm for cardiovascular disease, acknowledging the intricate relationship between obesity and heart health while providing a new therapeutic option for at-risk patients.
