The Government has announced a new collaboration with Novartis to provide a twice-yearly cholesterol injection that has the potential to save up to 30,000 lives over the next 10 years
The yet to be approved drug inclisiran will be studied in UK patients as part of a large-scale NHS clinical trial expected to start later this year. It 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.
Heart disease is the world’s biggest killer and the second biggest cause of death in the UK, with over three million people suffering from atherosclerotic cardiovascular disease and two and a half million currently relying on statins to lower their cholesterol. Recent trials have shown inclisiran can halve bad cholesterol in just two weeks.
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."
NICE approval will be sought as soon as 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.
Innovative and groundbreaking collaboration for heart disease patients
Inclisiran, potentially the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class, is an investigational twice-yearly therapy in Phase III clinical development. As a siRNA, inclisiran harnesses the body’s natural process of RNA interference to specifically prevent production of the PCSK9 protein in the liver, which enhances the liver’s ability to remove LDL-C from the bloodstream, thereby lowering LDL-C levels. Inclisiran is not yet approved by the FDA or any other regulatory authority.
Lord Prior, chair of NHS England, added: "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. 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.
"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 Government said in its release that over the past decade, the pharmaceutical industry has largely stopped finding solutions for large public health issues, such as diabetes, cardiovascular disease and obesity, due to the large costs developing new treatments. But the UK is paving the way to overcome this by making development, manufacturing and route to market faster, cheaper and more efficient for all parties.