THE Therapeutic Goods Administration (TGA) has approved Wegovy 2.4mg (semaglutide) to be used as a complementary therapy for reducing major adverse cardiovascular events, such as cardiovascular death, non-fatal myocardial infarction (heart attack), or non-fatal stroke.
The approval follows findings from an international study involving more than 17,000 participants across 41 countries, including Australia, which showed that Wegovy reduced cardiovascular events by 20% in people with pre-existing heart disease who were overweight or obese but did not have diabetes.
Wegovy is the same drug as Ozempic, but is indicated for chronic weight management, whereas Ozempic is indicated for management of type 2 diabetes.
They also have different dosages and delivery devices.
Both drugs are manufactured by Novo Nordisk.
"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," said cardiologist Professor Stephen Nicholls, Director of the Victorian Heart Institute at Monash University.
"It reinforces that these risks can be actively reduced with targeted therapies," headded.
Professor Nicholls was the leader of the Australian arm of the international study, and said the trial demonstrated that the drug's cardiovascular benefits 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 said.
"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."
For many, however, the benefits will be unattainable - the drug is not PBS-listed and costs up to $500 per month via private prescription.
Novo Nordisk has indicated it will reapply for PBS listing in light of the new TGA approval. KB
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