NHS to make unapproved heart disease drug available to patients by 2021

Novartis office

A new heart disease drug is expected to be made available to patients by 2021, through a collaboration between Novartis, NHS England, the National Institute for Health Research and Oxford University.

Incliseran, a bi-annual injection and potentially the first and only cholesterol-lowering therapy in the small-interfering RNA (siRNA) drug class, will be studied in UK patients as part of a large-scale phase III clinical trial, expected to start later in 2020.

The drug will be used as a preventative add-on treatment for statins in patients who have already been diagnosed with cardiovascular disease (CVD), with the expectation that it could prevent 55,000 heart attacks and strokes annually and has the potential to save 30,000 lives in the next ten years.

It will also be put through the National Institute for Health and Care Excellence’s approval programme and NHS England will agree a population-level commercial arrangement with the drug’s manufacturer, Novartis, to make it available to patients as soon as 2021.

Lord David Prior, chair of NHS England, said that the “innovative” collaboration could transform the health outlook of tens of thousands of people living with CVD.

“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.”

Inclisiran is not yet approved by the US Food and Drug Administration or any other regulatory authority.

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Citation
The Pharmaceutical Journal, PJ, January 2020, Vol 304, No 7933;304(7933):DOI:10.1211/PJ.2020.20207566