Novartis AG is scrapping a high-profile UK clinical trial once touted as an example of National Health Service collaboration, even as the government tries to smooth the path for other studies and restore the country’s status as a destination for groundbreaking research.
(Bloomberg) — Novartis AG is scrapping a high-profile UK clinical trial once touted as an example of National Health Service collaboration, even as the government tries to smooth the path for other studies and restore the country’s status as a destination for groundbreaking research.
The Swiss drugmaker said it has decided not to move forward with Orion-17, a study announced in early 2020 as part of a broader cooperation with the UK government to get a new heart drug to patients.
The Novartis decision comes as the government announces the biggest overhaul in UK clinical-trial regulation in more than 20 years to kickstart the country’s faltering life-science ambitions.
One proposal is to combine the Medicines and Healthcare Products Regulatory Agency and research ethics reviews, making the application processes faster for drugmakers trying to bring new medicines to patients.
Read More: Here’s a Radical Tactic to Bypass UK Health Logjam: Look Abroad
The abandoned study sought to test a medicine called Leqvio on people with high cholesterol who haven’t had a heart attack or stroke — a massive group of potential patients. Instead, Novartis this month started an international trial of people with the same profile, which will include sites in the UK.
The halted study was a prime example of the type of partnership the government has pursued: leveraging the NHS’s scale to find patients best suited to a new therapy.
Never Started
The Covid-19 pandemic and ongoing NHS crisis have left doctors and scientists with less time to address other research. For example, the University of Oxford team that would have helped to lead the canceled Novartis trial ran a more than 47,000-person study called Recovery, which delivered crucial results on how a range of treatments performed against Covid.
The Orion-17 trial was announced just before the pandemic hit, and never got underway. The study would have been the first in the world to treat such a broad patient population, the UK government said at the time. A government partnership to help treat a smaller group of patients — people who’ve already had a heart attack or stroke — is still proceeding.
Another Novartis-Oxford study, dubbed Orion-4, had to pause enrollment in 2020 as the first waves of Covid infections swept across the country.
The UK’s overhaul comes in response to a precipitous drop in clinical trials. The number of studies initiated in the country fell by 41% between 2017 and 2021, according to a report published by the Association of the British Pharmaceutical Industry last year, which also found studies are slower to get started.
Other proposed measures proposed include reviewing applications within 30 days, removing duplicate requirements, and allowing trials with a risk similar to standard medical care to be approved without regulatory review. The government will also give guidance on diversity in trials, without imposing targets or quotas.
The reforms come a few days after Chancellor of the Exchequer Jeremy Hunt unveiled plans to fast-track the approval of new drugs. In the budget, the government gave the MHRA, the UK medicines watchdog, £10 million ($12 million) to explore partnerships with agencies overseas, including the US, Japan and elsewhere in Europe.
Read More: Britain’s Health Watchdog to Speed Up Drug Approvals
More stories like this are available on bloomberg.com
©2023 Bloomberg L.P.