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Cholesterol-busting jab to go on trial in NHS

World-first population-level deal announced

Jo Carlowe

Tuesday, 14 January 2020

The NHS is to pioneer a bi-annual injection to lower cholesterol and protect heart health.

Announcing the trial in a statement today, the Department of Health and Social Care, believes up to 30,000 lives could be saved over the next decade thanks to the proposed government collaboration with pharmaceutical company Novartis.

The yet to be approved drug inclisiran, a treatment to lower cholesterol, will be studied in UK patients as part of a large-scale NHS clinical trial expected to start later this year. In a world-first, the drug is expected to be available through a population-level agreement.

Early results from clinical trials suggest that if inclisiran is given to 300,000 patients annually, it could help prevent 55,000 heart attacks and strokes, and has the potential of saving 30,000 lives in the next 10 years.

Heart disease is the world’s biggest killer and the second biggest cause of death in the UK, with over 3 million people suffering from atherosclerotic cardiovascular disease and 2.5 million currently relying on statins to lower their cholesterol.

Health and Social Care Secretary Matt Hancock said: “As Health Secretary, I’m determined find ways to save as many lives as possible, and to do my best to stop terrible conditions like heart disease from taking people from their family and friends far too soon. This partnership is fantastic news and is a huge stride forwards in helping to achieve this. This collaboration has the potential to save 30,000 lives over the next 10 years and is proof that the UK continues to be the world-leading destination for revolutionary healthcare.”

Inclisiran, a bi-annual injection, is expected to be filed for approval as a preventative add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease later this year.

It will also be put through the National Institute for Health and Care Excellence’s (NICE) approval programme and NHS England will agree a population-level commercial arrangement with the company to make it widely available to patients as soon as 2021.

Commenting on the collaboration between Novartis, NHS England, the National Institute for Health Research (NIHR), and Oxford University, the chair of NHS England Lord David Prior said: “This innovative and groundbreaking collaboration could transform the health outlook of tens of thousands of people suffering from heart disease, by bringing together in a unique combination our ability to organise large scale clinical trials, to address highly complex manufacturing issues, and to reach a large population of patients.

“It is a great illustration of how the UK Life Sciences Strategy can help both NHS patients and the wider economy, and shows that the UK can be the centre of a dynamic life sciences ecosystem whilst delivering great care.”

Professor of Medicine and Epidemiology at the University of Oxford Martin Landray said: “This trial provides an opportunity to demonstrate how a highly streamlined trial can be conducted within the UK by combining elements of patients already diagnosed with cardiovascular disease and receiving treatment through the successful ORION-4 trial, with the high-throughput clinics developed for UK Biobank. The trial will provide both a very reliable test of the efficacy and safety of inclisiran to support a population-health approach to the management of cholesterol, and act as an exemplar for future trials of other treatments in the UK.”

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