The therapy involves treating individuals with atherosclerotic cardiovascular disease.
Novartis has announced new long-term data from its ORION-8 clinical trial. The study is a phase 3 open-label extension of the company’s ORION-9, ORION-10, ORION-11 and ORION-3 trials.
Data emerging from the research has shown that incorporating twice-yearly dosing of Leqvio (also known as inclisiran) – in addition to statin therapy – provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six years.
The treatment involves individuals with atherosclerotic cardiovascular disease (ASCVD), an increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH).
ORION-8 has been the most expansive Leqvio study to date and continues to analyse the safety profile, long-term efficacy and tolerability of the candidate. In total there has been an exposure of more than 8,500 patient-years during the trial’s three-year follow-up.
Participants from all four previous ORION trials received inclisiran every six months for the three-year period, with 78% of patients reaching their pre-specified LDL-C targets. Meanwhile, on average, LDL-C levels were reduced by approximately 49%.
Gerrit Zijlstra, Novartis country medical head and chief medical officer at Novartis UK, was optimistic about the new data: “These results reaffirm our partnership-based approach with the NHS on the basis that administration through primary care could positively impact population health in the UK.
“This will help us to deliver our shared vision for the benefit of UK patients and contribute to reducing the considerable impact of CVD on the population.”
Kausik Ray, Professor of public health at Imperial College London and honorary consultant cardiologist at the Imperial College NHS Trust, reflected the importance of the results: “The present findings from the ORION-8 trial reconfirm and extend prior observations about the safety profile and efficacy of inclisiran for people with atherosclerotic cardiovascular disease and those at risk of cardiovascular disease, in whom cholesterol levels are not adequately controlled.”
He added: “The safety profile demonstrates no new additional concerns raised during this extended period of follow up. As the senior author in this trial and lead in the ORION development programme as well as an active clinician, I am acutely aware of the unmet clinical need in our patients but also the assurance needed by the clinical community for any novel therapy.”
The results were duly presented during a session at the European Society of Cardiology Congress 2023 in Amsterdam.