Novartis collaborates with UK government over new cholesterol treatment

A new drug for patients at risk of heart disease is to be made available to patients on the NHS in the UK after the government announced a collaboration with Novartis.

Inclisiran will be introduced on the NHS to offer cholesterol treatment and will be studied in UK patients as part of a large-scale NHS clinical trial due to start later this year.

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.

Health and social care secretary Matt Hancock said: “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.”

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. Recent trials have shown inclisiran can halve bad cholesterol in two weeks.

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 at the earliest opportunity possible and NHS England will agree a population-level commercial arrangement with the company to make it widely available to patients as soon as 2021.

As well as the NHS and Novartis, the study is supported by the National Institute for Health Research (NIHR) and Oxford University.

Novartis CEO Vas Narasimhan said: “Novartis has a unique opportunity with Inclisiran to use innovative population-based approaches to open up a new chapter for the treatment of cardiovascular disease, the world’s leading cause of mortality and disability.

“Novartis is excited to partner with the UK government to leverage innovative models that could potentially lead to generating leading scientific evidence, accelerate access for patients and ensure continuous improvement in manufacturing efficiency and optimisation.”

Professor of Medicine and Epidemiology at the University of Oxford Martin Landray added:

“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 cardiovascular disease and received 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.”