Novartis is halting a UK-based trial originally planned as part of a partnership with NHS England, a setback in its quest to win wider approval for its novel cholesterol-lowering drug to prevent heart attacks and strokes.
A spokesperson said that among the factors influencing the decision, the coronavirus pandemic had made it difficult to make progress on the trial.
Under the ORION-17 trial, planned to involve 40,000 patients, Novartis was trying to show that its Leqvio drug could prevent the first occurrence of major cardiovascular health problems in high-cholesterol patients, part of a broader collaboration with the British health system.
“After careful evaluation, we have decided not to move forward with ORION-17,” the Swiss drugmaker said in an emailed statement on Wednesday. “We continue to have very high ambitions for Leqvio.”
The drug is approved to prevent renewed cardiovascular crises like a heart attack or stroke in people who have already suffered one, known as secondary prevention.
Novartis said it would pursue a different global trial with 14,000 volunteers to show Leqvio’s potential in primary prevention in people at high risk of suffering a first cardiovascular event.
Leqvio, a twice-a-year injection, has had a slow ramp-up phase because cardiologists need to be persuaded to change their billing routines, but analysts have predicted a more than $2 billion sales opportunity from 2025. It would be among the company’s biggest growth drivers during that time.
Credit Suisse analysts said the withdrawal likely “reflects slow progress in initial UK roll out to (general practitioners) in secondary prevention”.
In 2021, Novartis said it had agreed a deal with Britain’s healthcare service provider over the use of Leqvio, after the country’s healthcare cost agency NICE approved the medicine.
The NHS said its wider “population health agreement” with Novartis, which covers secondary prevention, remains in place, adding it “is a pioneering approach to improving treatment for eligible patients with cardiovascular disease across the country.”
The Financial Times first reported that the trial would end.