The FDA has approved weight-loss drug Wegovy, the sister product of diabetes medication Ozempic, for use to treat heart disease.
The US Food and Drug Administration has approved Wegovy – which was originally approved for weight loss and contains the same active ingredient as diabetes-turned-weight-loss drug Ozempic – for yet another indication: heart disease.
Speaking to The Medical Republic, chair of the RACGP specific interest group on obesity Dr Terri-Lynne South said that she hoped the TGA would follow in the FDA’s footsteps.
“What [the FDA] is doing here is actually preventing one of the known complications of obesity, and in doing so potentially saving a lot of health dollars.
“Anything that we can do to stop the risks and consequences of the complications of obesity is something that we need to pursue as much as possible.”
The FDA approval followed the release of the first clinical evidence demonstrating that semaglutide reduced cardiovascular events in non-diabetics.
The study, which was published in the New England Journal of Medicine last November, found that there was a 20% risk reduction in heart attacks, stroke and death in the population of overweight or obese adults over 45 during the study period.
According to Dr South, the effectiveness of the drug, which is a GLP-1 agonist, at reducing cardiac events may be tied to the GLP-1 receptors found in the heart.
“We’re assuming that there are some mechanisms that have less to do with fat loss and more to do with what those receptors may be doing in heart tissue,” she said.
Unfortunately, semaglutide products such as Ozempic, are currently in short supply nationally and are expected to continue to be so throughout 2024.
Speaking to The Australian, cardiologist and CEO of the Victor Chang Cardiac Research Institute Professor Jason Kovacic said the use of drugs like Ozempic for heart disease “may become as routine as taking a statin” once they are cheaper and more widely available.
“Once the supply issue is fixed and there is adequate supply, I believe that few will argue against the appropriate use of these drugs in overweight and obese persons, in particular overweight and obese patients with heart disease, regardless of whether they have diabetes or not,” he said.
Dr South said that while the evidence didn’t show that semaglutide was suitable for a primary prevention intervention, as the study looked at patients with a history of heart disease, it did show that it may be suitable for secondary prevention.
“That’s where we know that there is significant need, because this is a higher risk population,” she said.
“It comes down to health economics.
“But certainly, if we can be having similar sorts of cardiovascular mortality reduction, but also [reduction in] non-fatal cardiovascular events, it behooves us to look at that in consideration with other medications that have had TGA approval and PBS listing for similar sorts of outcomes.”
Related
Dr South added that long-term safety would be an important consideration given the chronic nature of obesity.
“Any medication that [GPs] are looking at that ultimately is expected to be long term, we must consider longer term safety as part of the decision-making process.
“I think that if you believe that obesity is a chronic complex medical condition for which there is not necessarily any cure, but the ideal is to put it into remission, then we would be treating obesity as a chronic medical issue just like we do high blood pressure or type two diabetes or secondary prevention of cardiovascular disease.”
Dr South said she was confident that the FDA approval, as well as approvals in places like the UK, would put pressure on the Australian system to follow suit.
A spokesperson from the TGA told TMR that the regulator is currently evaluating an application from Novo Nordisk, which was submitted in January, “to extend the indications of Wegovy to include: “to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and BMI ≥27 kg/m2”.
“The legislated timeframe for TGA assessment is 255 working days for applications of this kind,” the spokesperson said.
“Timeframes may be shorter and are dependent on the quality of data submitted by sponsors.”
This article was updated 4.48pm 8 April 2023 to include comments from the Therapeutic Goods Administration.
