TGA approves Wegovy for reducing MACE risk

Doctors can now prescribe the GLP-1 receptor agonist for patients with overweight, established CVD and no history of diabetes.
Professor Mark Harris
Professor Mark Harris.

The TGA has approved Wegovy to reduce the risk of major adverse events in patients with cardiovascular disease who are overweight or obese.

The once-weekly injectable semaglutide formulation hit Australian shelves last August, two years after it received TGA approval for weight loss.

Under the expanded indication, doctors can prescribe the GLP-1 receptor agonist for patients with overweight (BMI ≥27kg/m2), established CVD and no history of diabetes.

The TGA decision followed results from a phase III sponsor-funded clinical trial published in the New England Journal of Medicine, which showed that semaglutide was associated with a 20% reduced risk of major adverse cardiac events compared with placebo.