The Government has announced an in-principle agreement with Novartis to introduce its investigational drug inclisiran as a preventative add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease. 

Recent trials have shown that the twice-yearly cholesterol injection can halve LDL cholesterol in just two weeks. It will be studied in UK patients as part of a large-scale NHS clinical trial expected to start later this year.

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.

What is inclisiran?

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.

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.

The collaboration is between Novartis, NHS England, the National Institute for Health Research (NIHR), and Oxford University.

Innovative manufacturing research collaboration 

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."

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.