Novartis' inclisiran will be put through the National Institute for Health and Care Excellence’s (NICE) approval programme at the earliest possible opportunity

The government on Monday announced a collaboration with Novartis to launch a clinical trial for ‘yet to be approved’ drug inclisiran.

The drug could benefit thousands of patients at risk of heart disease in coming years.

The ground-breaking collaboration includes Novartis, NHS England and the National Institute for Health Research (NIHR) and Oxford University.

The Department of Health and Social Care (DHSC) expects this to position the UK as a world-leading destination to develop cutting-edge treatments.

Inclisiran, a treatment to lower cholesterol, will be studied in UK patients as part of the large-scale NHS clinical trial expected to start later this year.

According to DHSC, early clinical trial results suggest that the drug could help prevent 55,000 heart attacks and strokes if it is given to 300,000 patients annually.

Health 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 ten years and is proof that the UK continues to be the world-leading destination for revolutionary healthcare.”

Given as a bi-annual injection, inclisiran is expected to file for approval as a preventive add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease.

The drug will also be put through the National Institute for Health and Care Excellence’s approval programme at the earliest possible opportunity and NHS England will agree on a population-level commercial agreement with Novartis to make it available to patients as soon as 2021.

“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,” said Lord Prior, chair of NHS England, who announced the collaboration at the J.P. Morgan healthcare conference in San Francisco.

The newly announced collaboration will also create an industry and academic consortium to improve the country’s efficiency in manufacturing innovative medicines.

Vas Narasimhan, Novartis’ CEO, said: “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 optimization.”

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