First PBS-listed drug to reduce cardiovascular risk in high triglyceride patients

Pharma News: Many patients remain at an elevated risk for heart attack, stroke, or other major cardiovascular events despite therapeutic management of cholesterol and triglycerides. CSL Seqirus has secured the Pharmaceutical Benefits Scheme (PBS) listing of Vazkepa (icosapent ethyl), marking the first reimbursed medicine to reduce the risk of heart attack and stroke in adult statin-treated patients with elevated triglycerides and high cardiovascular (CV) risk.

Last year, Seqirus and Amarin signed an exclusive license and distribution agreement to commercialise Vazkepa in Australia and New Zealand. Under this partnership, Amarin oversees product supply, while Seqirus handles the commercialisation efforts in both markets.

Vazkepa stands out as the only purified eicosapentaenoic acid (EPA)-based omega-3 fatty acid to receive Therapeutic Goods Administration (TGA) approval. Elevated triglycerides, an independent predictor of CV risk, further complicate the challenge of preventing cardiovascular events in patients who have already suffered from one.

“The burden of cardiovascular disease in Australia is immense,” said Professor Stephen Nicholls, Director of the Victorian Heart Hospital and Professor of Cardiology at Monash University. “It is Australia’s leading cause of death, 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 experience another major CV event within seven years.

Professor Nicholls added, “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 gives us, for the first time, a treatment option proven to reduce CV risk factors for our eligible patients with high triglycerides,” he explained. “It’s an additional preventative option that we haven’t had in the past and allows us to do more for our patients.”

The Pharmaceutical Benefits Advisory Committee (PBAC) initially rejected Vazkepa, citing a low clinical need due to existing therapies and concerns over cost. However, following a resubmission in March, the committee ultimately endorsed the medicine, recognising the significant and ongoing impact of cardiovascular disease in Australia, which accounts for a quarter of all deaths and over 1,500 hospitalisations daily.

Vazkepa’s landmark REDUCE-IT study showed that the medicine reduced the relative risk of cardiovascular events by 25% when added to statin therapy, compared to statin therapy alone. The trial, which involved over 8,000 patients, demonstrated that 17.2% of those treated with Vazkepa experienced a major cardiovascular event, versus 22% in the placebo group, over a median follow-up period of nearly five years (p<0.0015).

Internationally, Vazkepa has received recognition from over 42 medical societies and guidelines, including the American Heart Association (AHA) and the European Society of Cardiology (ESC), further supporting its role in the long-term management of cardiovascular risk factors.

Claire Morgan, Medical Director at CSL Seqirus, said “As an Australian company, CSL is committed to driving forward access to innovative treatments for health conditions that present a high burden to the Australian community.

“We are proud to be expanding our broad portfolio of in-licensed medicines into the cardiovascular space to help address an unmet need for patients.”

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