Novartis on Monday announced that it reached a deal with NHS England that could potentially make the RNAi-based PCSK9 inhibitor inclisiran, acquired via its recent $9.7-billion takeover of The Medicines Company, broadly available as soon as 2021. The pact also calls for the investigational cholesterol-lowering drug to be studied in UK patients in the primary prevention setting as part of a large-scale trial expected to start later this year, as well as for a collaboration on the manufacture of similar therapies. Financial details were not disclosed.
"Novartis has a unique opportunity with inclisiran to open up a new chapter in the treatment of cardiovascular disease," commented CEO Vas Narasimhan, adding 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."
Inclisiran, which is administered via twice-yearly injection, is currently in Phase III testing as a preventative add-on treatment to statins for atherosclerotic cardiovascular disease (ASCVD) patients, with an EU filing anticipated in the first quarter. Novartis said that upon regulatory approval and assessment by the National Institute for Health and Care Excellence, the first proposal in its NHS tie-up would be to provide inclisiran to these secondary prevention ASCVD patients through a "world-first" population health model that encompasses a "large at-risk NHS patient population."
According to the NHS, this "game-changing" approach is expected to make a "significant contribution" towards the agency's long-term goal of preventing 150,000 cardiovascular deaths over 10 years. The NHS cited data indicating that if inclisiran is given to 300,000 patients annually, it could help prevent 55,000 heart attacks and strokes, with the potential of saving 30,000 lives in the next decade.
Meanwhile, the second proposal involves the large-scale clinical trial to evaluate inclisiran for primary prevention in patients at very high risk of having their first cardiac event. Martin Landray, principal investigator of the ongoing Phase III ORION-4 trial of inclisiran in ASCVD patients who have already suffered a heart attack or stroke, or who have had a procedure to treat blocked arteries, said the new study "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."
Novartis has agreed to provide inclisiran injections free in exchange for data from the five-year trial, which will be carried out by NHS staff. Once the drug is approved and has gone through a cost-effectiveness evaluation by NICE, expected in 2021, the drug's price will have to be negotiated with the company.
The Swiss drugmaker said the final proposal includes the creation of an industry and academic consortium to look at "manufacturing synergies that could improve the efficiency and scale" at which the UK can produce oligonucleotide medicines, such as inclisiran.
For related analysis, see ViewPoints: Novartis bets big on The Medicines Company. See also ViewPoints: Inclisiran’s risk/benefit may be getting too solid to ignore.
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