Novartis scraps large-scale UK study of cholesterol-lowering drug Leqvio

22 Mar 2023
firstwordpharma.com
Clinical Study
Novartis said Wednesday that it will no longer support a large-scale study of its cholesterol-lowering therapy Leqvio (inclisiran) in the UK, which was to be conducted under a partnership with the NHS announced in 2020. "After careful evaluation, we have decided not to move forward with ORION-17," a company spokesperson noted, dealing a further blow to the UK's life sciences ambitions.
The spokesperson explained that Novartis took the decision after weighing "several factors that drive investment decisions in research and development activities and plans for [Leqvio] in the UK." The ORION-17 trial had been expected to evaluate the RNAi-based PCSK9 inhibitorPCSK9 inhibitor for primary prevention in 40,000 patients at very high risk of having their first cardiac event. The drugmaker had agreed to provide the product free of charge in exchange for data from the five-year study.
Martin Landray, professor of medicine and epidemiology at Oxford university, whose team had been due to run the ORION-17 trial, called Novartis' decision a "huge disappointment." Landray added "it is not a great advert for the UK's life sciences ambitions and it is driven not because of a weakness of the life sciences system, but a failure of implementation."
Low uptake
In 2021, the National Institute for Health and Care Excellence recommended use of Leqvio across England for people with primary hypercholesterolaemia or mixed dyslipidaemia who have already had a cardiovascular event such as a heart attack or stroke. The decision came after the NHS reached a "population health agreement" with Novartis enabling the therapy be given to 300,000 people over the first three years, a figure that could rise to nearly 500,000 beyond that initial period.
However, the Financial Times, citing people familiar with the matter, suggested that the initial rollout of Leqvio via GPs had resulted in low uptake, prompting Novartis to rethink its plans. According to the sources, many GPs had been reluctant to prescribe the medicine, saying instead that the rollout should be led by hospital doctors with more capacity to monitor side effects.
The sources added that Novartis will now run a similar trial itself around the world.
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