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UK, Novartis firm collaborating for new cholesterol treatment
The UK government is collaborating with pharmaceutical company Novartis to launch a clinical trial for new cholesterol treatment.
Up to 30,000 lives could be saved over the next decade thanks to a proposed pioneering government collaboration with pharmaceutical company Novartis to tackle heart disease – a leading cause of death in the UK.
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. Additionally in a world-first, the drug is expected to be available through a population-level agreement – pioneering a game-changing approach to reducing the risk of heart disease.
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 and a half million currently relying on statins to lower their cholesterol. Recent trials have shown inclisiran can halve bad cholesterol in just 2 weeks.
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.
“I will always help the NHS reach its full potential, and novel and innovative collaborations such as this put patients at the forefront of the most promising medical breakthroughs.”
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 program 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.
The agreement will make a significant contribution towards meeting the NHS Long Term Plan commitment to preventing 150,000 cardiovascular deaths over 10 years.
The collaboration between Novartis, NHS England, the National Institute for Health Research (NIHR), and Oxford University represents an innovative approach to tackling major public health issues and positions the UK as a world-leading destination to develop revolutionary medicines.
Lord Prior, chair of NHS England, 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 organize 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.
The collaboration also includes the creation of an industry and academic consortium to improve the efficiency in which the UK can manufacture for this form of innovative medicine.
The unique population health model used by the UK will enable the collaboration to address the needs of patients and health systems that have previously not been able to be met on a large scale. The new cost-effective process will lead the way for innovative approaches to helping meet large-scale, public health concerns.
This highlights the UK as a prime destination to get new medicines to patients faster and more cost-effectively. Its appetite for innovation, unrivalled infrastructure and world-leading joined-up healthcare system offers the opportunity for similar deals to be done for other drug development projects of this scale.
The UK plans to remain at the forefront of the global life sciences industry, giving our NHS and patients faster access to innovative medicines while supporting the growth of the sector.
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 optimization.
Professor Sir John Bell said “The discovery and development of Inclisiran marks an important change in the approach to pharmaceutical interventions for public health. This program has introduced the use of health care system data from the NHS to dramatically reduce costs by rapidly identifying patient populations through health records.”
“I am excited by this collaboration which is likely to have far-reaching impact on the way population level disease therapies are developed in the life sciences sector.
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 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.
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