Novartis pulls plug on landmark UK cholesterol trial

Novartis has confirmed that it is no longer going ahead with a large-scale clinical trial of its cholesterol-lowering therapy Leqvio in the UK, but said other elements of a partnership with NHS England on the drug remain intact.

The ORION-17 study was at the heart of a three-part deal between the UK government and Novartis, first announced in 2020, alongside an access agreement to accelerate uptake and the creation of a consortium to improve the manufacturing of oligonucleotide drugs like Leqvio (inclisiran).

At the time, it was hailed as a landmark, population-level agreement that would ensure the much-anticipated twice-yearly therapy – which wasn’t approved for marketing at that point – would be “coming to the UK first“.

The large-scale trial – involving up to 40,000 patients – was going to explore the use of inclisiran as primary prevention; in other words, to stop high-risk patients from having their first cardiac event.

Fast forward to today, and some of the shine has now been taken off the alliance. Novartis confirmed in a statement to pharmaphorum that it decided not to move forward with the ORION-17 primary prevention trial as it is now running a global study – called VictORION-1-PREVENT trial (V1P) – that started in mid-March, ahead of schedule.

Also a primary prevention trial, V1P aims to enrol 14,000 patients across 42 countries, including the UK and the US.

“The collaboration between Novartis and NHS England is vital to addressing the key risk factor of elevated LDL-C levels in cardiovascular disease," said the company.

“Both parties remain fully committed to the partnership, and to Leqvio, which has already seen significantly faster patient uptake in the UK relative to the launch of other lipid-management therapies used in combination with statins,” it added.

There’s no question, however, that the decision is a disappointment, given that the clinical research sector in the UK seems to be back-pedalling, prompting the government to launch a review into the sector.

Leqvio was approved in Europe later in 2020, on the back of clinical trial data showing it could reduce LDL-cholesterol by up to 52% in patients unable to reach their cholesterol targets, despite taking the maximum tolerable dose of statins.

Despite its clinical promise, the drug has yet to fulfil its commercial potential, with sales of $112 million last year, although last month Novartis said it expects acceleration in uptake in 2023, thanks to broader reimbursement coverage in the US, growth in the UK, and new approval and launches in Japan and China.