Novartis AG signed a deal with Britain's National Health Service to launch a clinical trial for its newly acquired heart drug inclisiran in the country, according to a Jan. 13 release by the NHS.
The NHS said it will collaborate with the Swiss drugmaker to launch a clinical trial and to conduct manufacturing research. The trial will be part of a large-scale NHS study that is slated to start later in 2020.
As part of the deal inclisiran, administered to patients by a twice-yearly injection, will be put up for approval by the U.K.'s price watchdog, the National Institute for Health and Care Excellence at the earliest opportunity possible, and NHS England will come up with a commercial arrangement with Novartis to make the drug available to patients in the country as soon as 2021, according to the NHS release.
Novartis bought inclisiran through the $9.7 billion acquisition of Parsippany, NJ-based The Medicines Co. The drug, still in late-stage clinical study, aims to reduce the risk of heart disease through lowering patients' cholesterol levels by interfering with RNA expression. Recent trials have shown that the drug can halve levels of the low-density lipoprotein, also known as bad cholesterol, in two weeks.
The Medicines Co. said in November 2019, prior to its acquisition by Novartis, that it would submit inclisiran for U.S. Food and Drug Administration approval in the fourth quarter of 2019 and for European Medicines Agency approval in the first quarter of 2020.
Heart disease is the second biggest cause of death in the U.K., with more than 3 million people suffering from atherosclerotic cardiovascular disease, the release said.