Australia’s Therapeutic Goods Administration (TGA) has approved Wegovy, a weight-loss medication from Danish pharmaceutical company Novo Nordisk, for the treatment of cardiovascular disease in overweight and obese patients. This decision marks a significant expansion in the use of GLP-1 class drugs, which were originally developed to treat diabetes and, more recently, obesity.
Novo Nordisk estimates that as many as 3.5 million Australians could be eligible for the new treatment under this approval. The move follows a growing body of research highlighting the cardiovascular benefits of Wegovy, which contains the active ingredient semaglutide. The TGA’s decision broadens the drug’s application beyond its initial use for weight management and signals a shift towards addressing heart disease related to obesity.
A Broader Role for Semaglutide
Wegovy’s approval for heart disease follows a global study involving 17,000 participants across 40 countries, which demonstrated that the drug reduces cardiovascular events by 20 percent in people with pre-existing heart conditions, including heart attacks and strokes. This study, which was published in late 2023, found significant benefits for overweight or obese individuals who did not have diabetes. The U.S. Food and Drug Administration (FDA) approved Wegovy for heart disease treatment in May 2024.
Dr. Stephen Nicholls, a cardiologist and the Australian lead for the global study, noted that this approval underscores the importance of tackling obesity as a critical risk factor for heart disease. “This highlights the vital role of overweight and obesity as major drivers of heart disease—on par with cholesterol, blood pressure, diabetes, and smoking,” he said. “The findings reinforce that these risks can be actively mitigated with targeted therapies.”
The Road to Pharmaceutical Benefits Scheme (PBS) Listing
Despite the promising approval, the cost of Wegovy remains a significant barrier for many Australians. The drug, which costs between $345 and $645 per month, is currently not listed on the Pharmaceutical Benefits Scheme (PBS). Without this listing, patients must pay the full price, limiting access to those who can afford it.
Novo Nordisk has previously sought PBS listing for Wegovy, but two applications have been rejected. The company’s vice president of clinical, medical, regulatory, and pharmacovigilance, Ana Svensson, confirmed that Novo Nordisk plans to resubmit the application for PBS listing in 2025. “We always had a plan to resubmit again, so we are planning to do that in 2025 because it is very important to enable access to all the eligible patients here in Australia who require the product,” Svensson said.
While only Ozempic, another GLP-1 medication from Novo Nordisk, is currently listed on the PBS for diabetes treatment, experts hope that this approval will pave the way for wider government funding for obesity-related drugs. Svensson also reassured Australians that there would be no supply issues with Wegovy. “We have worked hard for the past two years to ensure once we launch Wegovy here in Australia, patients will have access and continue with their treatment,” she said.
Competing Drug Manufacturers Push for PBS Listing
Eli Lilly, the American pharmaceutical company behind the rival weight-loss drug Mounjaro, has also called for its product, which also contains a GLP-1 receptor agonist, to be included in the PBS. Both Novo Nordisk and Eli Lilly are pushing for a broader acceptance of obesity treatments under the PBS to ensure better access for Australian patients.
Access to Treatment Amid Shortages
While Wegovy’s approval offers hope, Australia is currently facing a shortage of Ozempic, with the TGA indicating that supply issues are expected to persist until the end of 2025. However, Wegovy’s availability will not be affected, according to Novo Nordisk.
Wegovy’s TGA approval offers new possibilities for treating heart disease in millions of Australians affected by obesity and cardiovascular conditions. However, with high drug costs and the ongoing PBS listing process, access remains a key challenge that patients and healthcare advocates will continue to monitor in the coming year.
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