CSL Seqirus has welcomed the PBS listing of Vazkepa (icosapent ethyl), a new treatment aimed at reducing the risk of heart attacks and strokes in adult patients who are already on statins but have elevated triglycerides and are at high cardiovascular risk.
Cardiovascular disease (CVD) is the leading cause of death in Australia, with 98,000 Australians experiencing a heart attack or stroke each year.
Approximately one in three people who have had a heart attack or stroke will face another major cardiovascular event within seven years.
Patients with elevated cholesterol and triglycerides also remain at increased risk despite managing their conditions with statins.
Vazkepa is the first reimbursed treatment in Australia that specifically targets elevated triglycerides and helps reduce the likelihood of recurrent cardiovascular events.
It is also the only purified eicosapentaenoic acid omega-3 fatty acid approved by the TGA.
Prof Stephen Nicholls, Director of the Victorian Heart Hospital, emphasised the significance of this development, saying, "patients with high triglycerides who have had a cardiovascular event in the last 12 months are at high risk of another event and there's a particular urgency to be able to reduce the risk for these patients".
"The reimbursement of Vazkepa provides a new preventive treatment option to reduce their risk," Nicholls said.
The PBS listing follows the results of the REDUCE-IT trial, which demonstrated that Vazkepa, in conjunction with statins, reduced the risk of major cardiovascular events by 25% compared to statin therapy alone.
The trial involved over 8,000 statin-treated patients and showed significant reductions in events like heart attacks and strokes.
Claire Morgan, Medical Director at CSL Seqirus, said, "as an Australian company we are proud to be expanding our broad portfolio of in-licensed medicines into the cardiovascular space to help address an unmet need for many patients".
Vazkepa's approval and PBS listing marks a step forward in reducing the burden of CVD disease in Australia, Morgan added. JG
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