New cholesterol medicine to be launched locally in the next two years

Pharma News: Australian experts have welcomed the news of a gamechanger cholesterol-lowering medicine, following results of the four-year clinical trial involving 14,000 people in 32 countries, including Australia, that were presented at the American College of Cardiology’s Annual Scientific Meeting on the weekend.

Through the trial, the new cholesterol-lowering drug, bempedoic acid, lowered low-density lipoprotein (LDL) cholesterol (bad cholesterol) by 20-25%, reduced cardiovascular complications by 13%, reduced heart attacks by 23%, and reduced coronary revascularisations (a procedure to open blocked arteries) by 19%.

Professor Stephen Nicholls, a cardiologist and Director of the new Victorian Heart Hospital at Monash Health and Monash University’s Victorian Heart Institute, co-led the landmark worldwide trial.

He said “This new drug provides another option for lowering cholesterol and is particularly important for patients that cannot tolerate statins. That’s a real problem in clinical practice which limits our ability to effectively lower cholesterol in many patients,’’ Prof Nicholls said.

“It has the potential to help between 100,000 and 500,000 people in Australia.’’

The new bempedoic acid drug, Nexletol, is being developed by US-based Esperion Therapeutics and will go to the Therapeutics Goods Administration for approval for use in Australia.

Esperion is positioning the drug as another option for people with heart disease who can’t or don’t want to take statins, as it doesn’t come with the muscle side effects of statins and it’s easier to use than injectable PCSK9 inhibitors.

Sheldon Koenig, president and CEO of Esperion, said “These results are practice changing and exceed our expectations. We expect applicable treatment guidelines to be updated quickly which will then lead to a paradigm shift in patient care. Based upon the strength of the data and the clinical significance they represent, we will be filing with the FDA and EMA by June 2023 and anticipate receipt of expanded CV risk reduction labels in 1H 2024 that will more than double the addressable treatment population.”

Professor Nicholls said he expected the drug to be available for Australian patients in the next two years. The company believes that it remains on track to submit regulatory filings to the FDA and EMA in 1H 2023.

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