A twice-a-year injection that reduces bad cholesterol to protect the heart is to be pioneered by the National Health Service (NHS) in England, reports BBC News. Already, millions of people take daily statin pills to cut their cholesterol. But later this year, a “ground-breaking” large-scale clinical trial will offer NHS patients a new form of medicine, gene silencing, in an injection called inclisiran.
Health Secretary Matt Hancock said the initiative could save 30,000 lives during the next decade. By “silencing” the PCSK9 gene, inclisiran can make the liver absorb more “bad” cholesterol from the blood and break it down. Trials presented at the European Society of Cardiology last year showed it could cut bad cholesterol levels in half within weeks.
Professor Kausik Ray, who led those trials, from Imperial College London, says this gives it “enormous” potential. NHS patients who have not had a heart attack or stroke but are at high risk of having one will be invited to take part in the latest trial.
Inclisiran will also be assessed for more routine use next year based on evidence from previous trials. At the moment – because of the way decisions on health are devolved within the UK – the announcement applies only in England.
Professor Jacob George, from the University of Dundee, said: “Whilst inclisiran has not yet been assessed by the European Medicines Agency or the US Food and Drug Administration (FDA), giving patients access to these innovative new medications within the safety confines of a large-scale trial is welcome news.”
Dr Riyaz Patel, clinical lead for cardiovascular disease prevention at Barts Health NHS Trust, said: “This as a really exciting announcement that changes the way we bring new medicines to patients earlier and [will] also propel the NHS and the UK as a world leader in this sort of clinical research.
“It is certainly a welcome step forwards to get exciting new drugs to patients quickly and safely.”
The drug, which is pending approval in the US, will be provided on a “population basis” to patients with atherosclerosis in the UK once it is tested in a large clinical trial and approved for use there, reports CNBC. Atherosclerosis is a devastating heart disease in which plaque builds up inside arteries and can lead to serious problems, including heart attack, stroke or death.
“Novartis has a unique opportunity with inclisiran to open up a new chapter in the treatment of cardiovascular disease, the world’s leading cause of mortality and disability,” Novartis CEO Vas Narasimhan is quoted in the report as saying. The company didn’t immediately release any financial details on the deal.
“We’re confident that innovative approaches like this will enable us to accelerate access timelines, deliver on our broader commitment to generating leading scientific evidence, and ensure continuous improvement in manufacturing efficiency and optimisation,” he said.
The report says Novartis picked up the heart drug as part of its completed $9.7bn acquisition of The Medicines Company, challenging Amgen’s Repatha and Sanofi’s and Regeneron’s Praluent, which target the same protein as inclisiran. The company expects to file the drug with European regulators in the first quarter of this year.
Hancock said that the deal is “a strong vote of confidence in our world-leading life sciences sector” that enables high-risk heart patients “to benefit from this potentially game-changing treatment.” “I am committed to helping the NHS reach its full potential, and innovative collaborations such as this puts patients at the forefront of the most promising medical breakthroughs,” he added, referring to the NHS.
Inclisiran was submitted to US regulators last year, and Novartis expects a European submission in coming weeks. Reuters Health reports that the pact also calls for a UK clinical trial, based on proprietary NHS data, to identify patients at risk of heart disease for whom conventional treatment has not worked, as well as a collaboration on manufacture of cutting-edge drugs like inclisiran, which targets “bad cholesterol”, a culprit behind heart attacks and strokes.
“If licensed, it will allow the drug to be put through the NICE approval process at the earliest opportunity possible, making it available to NHS patients much earlier,” the UK’s Department of Health and Social Care is quoted in the report as saying.
Naveed Sattar, professor of metabolic medicine at the University of Glasgow, was among those who said they thought the new injectable drug was very promising. But, reports The Guardian, he warned that so far only short-term trials had been carried out.
“Doctors are excited by inclisiran and the potential to ‘vaccinate’ against high cholesterol in some patients, with obvious benefits to compliance and uptake,” he said. “However, many would also like to see longer-term safety data from ongoing trials and to be told the cost of this new drug before they consider implications for care.”Full BBC News report Full CNBC report Full Reuters Health report Full report in The Guardian