Surprising new benefit of weight loss drug in Australia

In an Australian first, a weight loss drug has been approved for use to treat this common disease in obese and overweight patients.

For the first time a semaglutide weight loss drug has been approved for use in Australia to also treat cardiovascular disease in obese and overweight patients.

The Therapeutics Goods Administration (TGA) approval follows the results of a major clinical trial that showed semaglutide 2.4 mg (sold as Wegovy) reduced cardiovascular events in patients by 20 per cent.

Pharmaceutical company Novo Nordisk says the medication is the first indicated for weight loss and also for reducing major adverse cardiovascular events such as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

On its website the TGA says: “Wegovy is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, who are overweight or obese and do not have diabetes.

The drug was studied in the SELECT trial, a five-year international investigation of more than 17,000 adults from 41 countries including Australia.

Results were first published in late 2023. They found the weekly injection reduced major adverse cardiovascular events in people with pre-existing cardiovascular disease who were overweight or obese, but did not have diabetes.

While it is not taxpayer-funded, the medication has now been approved for the additional use by the TGA.

Professor Stephen Nicholls, director of the Monash University Victorian Heart Institute was lead of the Australian arm of the SELECT study.

Lead of the Australian arm of the study Professor Stephen Nicholls, who also leads the Victorian Heart Hospital, said while there was a lot of discussion about the risk of cholesterol, blood pressure, diabetes and smoking, the TGA approval re-emphasises the equal importance of overweight and obesity as a factor driving heart disease.

“Also key is that the risks associated can be reduced, and that there are therapies coming,” Professor Nicholls said.

He said the study found the reduction in risk wasn’t all related to weight loss.

“These drugs are also affecting inflammation and bad lipids and blood pressure,” Professor Nicholls said.

“What it tells us is that if you’ve got heart disease and if you are overweight or obese, that not only are you at a greater risk of having another heart attack, but that risk can be reduced.

“This has never been shown before and that’s a really important result and a great result for patients.”

He said if you draw a Venn diagram of people with heart disease and people who are overweight or obese, there was a significant overlap.

Novo Nordisk’s vice president of clinical, medical, regulatory and pharmacovigilance Dr Ana Svensson said it would apply again to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration (for the drug to be funded) armed with the results and the new indication from the TGA.

Wegovy has been shown to reduce cardiovascular events in patients by 20 per cent. Picture: Supplied

She said there were 4.5 million people in Australia with cardiovascular disease and 78 per cent were also obese or have overweight problems.

“Hence the need to have treatment options for those patients and help them. Weight loss has a significant impact on improving cardiovascular outcomes,” Dr Svensson said.

“We worked really hard over two years to invest in production because what we wanted, when we launched, was to enable people who started on treatment to have continuity of treatment,” Dr Svensson said.

“We really would like to be able to provide access to all patients that are eligible. We are determined to work with the Department of Health and the PBAC and others to see how we can make that happen.”

Common side effects of Wegovy can include nausea, diarrhoea, vomiting, constipation, dizziness, low blood sugar and fatigue.

Originally published as Surprising new benefit of weight loss drug in Australia