The FDA has approved the weight loss drug Wegovy, a sister drug to the diabetes drug Ozempic, for use in the treatment of heart disease.

The U.S. Food and Drug Administration has approved Wigoby, which contains the same active ingredient as Ozempic, a diabetes weight loss drug originally approved for weight loss, for yet another indication: heart disease.

talk to medical republicDr Terry Lynn South, chair of the obesity special interest group RACGP, said she expected the TGA to follow in the FDA’s footsteps.

“what [the FDA] What’s being done here is actually preventing one of the known complications of obesity, and doing so could potentially save you a lot of medical money.

“Everything we can do to stop the risks and consequences of obesity complications should be pursued wherever possible.”

The FDA’s approval followed the publication of initial clinical evidence demonstrating that semaglutide reduces cardiovascular events in non-diabetic patients.

The research published in New England Medical Journal Last November, it was found that the risk of heart attack, stroke and death was reduced by 20% in a group of overweight or obese adults aged 45 and over during the study period.

As a GLP-1 agonist, the drug’s effectiveness in reducing cardiac events may be related to GLP-1 receptors in the heart, Dr. South said.

“We think there are some mechanisms that have less to do with fat loss and more to do with what these receptors are doing in heart tissue,” she said.

Unfortunately, semaglutide products such as Ozempic are currently in short supply nationwide and are expected to remain in short supply through 2024.

talk to Australian personProfessor Jason Kovačić, a cardiologist and CEO of the Victor Chan Heart Institute, said the use of drugs like Ozempic for heart disease would be worse if these drugs became cheaper and more widely available than “taking a statin”. “It could become as commonplace as this.”

“Once supply issues are resolved and sufficient supply is available, we argue against the appropriate use of these drugs in overweight and obese people, with or without diabetes, and especially in overweight and obese heart disease patients. I don’t think there are many people,” he said.

Dr. South said the study looked at patients with a history of heart disease, and while there was no evidence that semaglutide was suitable as a primary prevention intervention, it may be suitable for secondary prevention. He said that he showed that there is.

“We know there is a great need in this area because it is a high-risk population,” she said.

“At the end of the day, it’s a health economics issue.

“But certainly if we could achieve a similar reduction in cardiovascular mortality, but also [reduction in] For non-fatal cardiovascular events, it should be considered with other drugs approved by the TGA and registered in the PBS for similar outcomes. ”

Dr. South added that given the chronic nature of obesity, long-term safety will be an important consideration.

“Any drug, [GPs] The end result is expected to be long-term, so long-term safety must be considered as part of the decision-making process.

“If we believe that obesity is a chronic, complex medical condition for which there is no necessarily cure, but that the ideal is to put it into remission, then we should treat obesity as a chronic medical problem, just like obesity. ” blood pressure, type 2 diabetes, and secondary prevention of cardiovascular disease. ”

Dr South said he believed FDA approval would put pressure on Australia’s system to follow suit, similar to approvals in countries such as the UK.

A TGA spokesperson said: TMR Regulators are currently evaluating an application from Novo Nordisk, which was submitted in January. The application “expands the indications for Wegovy to: reduce the risk of serious cardiovascular events in adults with pre-existing cardiovascular disease and a body mass index of 27 kg or more.” be. m2”.

“For applications of this type, the statutory period for TGA assessment is 255 working days,” the spokesperson said.

“The period could be even shorter and depends on the quality of data submitted by the sponsor.”

This article was updated on April 8, 2023, at 4:48 p.m., with comment from the Medicines Administration.