Novartis’ first in class cardiovascular medicine PBS listed, awaits data on heart attacks and stroke prevention

Pharma News: Novartis’ first-in-class cholesterol-lowering medicine has been included on the Pharmaceutical Benefits Scheme (PBS), effective April 1st. The twice yearly injection is a new option for patients with heterozygous familial hypercholesterolaemia (HeFH) and non-familial hypercholesterolaemia (non-FH) with atherosclerotic cardiovascular disease (ASCVD) that are not managed optimally on statins or ezetimibe.

An alarming four out of five ASCVD patients on statins fail to achieve the recommended low-density lipoprotein cholesterol (LDL-C) target, underscoring the urgent need for innovative solutions in cardiovascular medicine.

Leqvio (inclisiran), a small interfering RNA (siRNA), is the product of Novartis’ acquisition of The Medicines Company in 2019 for US$9.7 billion, targeting PCSK9 protein production and enhancing the liver’s capacity to process LDL-C. Clinical trials have demonstrated a reduction of approximately 50% in LDL-C levels.

Dr Karam Kostner, Associate Professor of Medicine at the University of Queensland and Director of Cardiology at Mater Hospital in Brisbane, emphasised the significance of this reimbursement.

“Cardiovascular disease represents a significant public health burden, with a quarter of all deaths in Australia attributable to CVD as an underling cause, and one in three Australian adults living with high cholesterol levels,” he said. “The availability of a first-of-its-kind siRNA therapy provides patients with another highly effective treatment option to help them control their LDL-C levels. This is a fantastic and welcome development in an area of high unmet need.”

Long-term data from ORION-8, a phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials revealed that Leqvio, when administered with statin therapy, delivered sustained LDL-C reduction over six years.

While in many cases, a lower LDL value translates to a lower heart attack risk, questions linger regarding Leqvio’s efficacy data in preventing heart attacks and strokes. Early insights suggest potential benefits for major adverse cardiovascular events (MACE) reduction. However, these findings await confirmation in the larger CV outcomes trials of longer duration.

Alternative CVD treatments such as Amgen’s Repatha (evolocumab) and Sanofi and Regeneron’s Praluent (alirocumab) – PCSK9 inhibitors injected once or twice a month – reduce the risk of major adverse cardiovascular events (MACE), stroke, and coronary revascularisation. According to a meta-analysis, Repatha had a positive effect on myocardial infarction, but no effects were noted for Praluent. The effects of both medicines on all-cause mortality and cardiovascular mortality were not statistically significant.

Tanya Hall, Founder and CEO of Hearts4Heart, stated “The introduction of a new treatment option is wonderful news for Australian patients. Continued innovation in the area of hypercholesterolaemia and atherosclerotic cardiovascular disease and timely access to the right treatment is essential for people living with these conditions.”

Matt Zeller, Country President of Novartis Australia and New Zealand, underscored the urgency of addressing the impact of cardiovascular disease, claiming one life every 12 minutes.

“Leqvio has the potential to transform patient care and help improve the lives of individuals living with CVD. We are committed to partnering with all stakeholders across the healthcare ecosystem to ensure patients will be able to access Leqvio in a timely manner, no matter where they live.

“Given the increased burden on our healthcare system and the inequalities often faced by rural and regional patients, we believe that pharmacists can also play a key role in helping patients administer and manage the therapy,” said Mr Zeller.

Looking ahead, Novartis has redirected its focus from the UK-based ORION-17 trial (despite a prior agreement with NHS England) to prioritise the VictORION-1-PREVENT trial, aiming to enrol patients across 50 countries.

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