Europe: On Wednesday day, August 30, 2023, Novartis has released significant long-term data from its ORION-8 clinical trial, marking a milestone in the treatment of atherosclerotic cardiovascular disease (ASCVD). The ORION-8 study represents a phase 3 open-label extension following the ORION-9, ORION-10, ORION-11, and ORION-3 trials.

The newly emerged data indicates that incorporating semiannual Leqvio (also known as inclisiran) dosing, in conjunction with statin therapy, consistently lowers low-density lipoprotein cholesterol (LDL-C) levels beyond the six-year mark. This groundbreaking therapy is tailored for individuals with ASCVD, an elevated ASCVD risk, or heterozygous familial hypercholesterolemia (HeFH).

ORION-8, the most extensive Leqvio study to date, continues to assess the candidate's long-term efficacy, safety profile, and tolerability. Over the course of the three-year follow-up, the trial has amassed data from more than 8,500 patient-years.

Participants from the preceding ORION trials received inclisiran every six months during this three-year period, with an impressive 78% of patients achieving their predefined LDL-C targets. On average, LDL-C levels registered a remarkable reduction of approximately 49%. These results were presented during a session at the European Society of Cardiology Congress 2023 in Amsterdam.

Gerrit Zijlstra, Novartis Country Medical Head and Chief Medical Officer at Novartis UK, expressed optimism about the new findings: "These results reaffirm our collaborative approach with the NHS, suggesting that primary care administration could positively impact the health of the UK population. This aligns with our shared vision to benefit UK patients and mitigate the significant burden of cardiovascular disease on the population."

This ORION-8 trial data reaffirms and extends prior observations regarding the safety and efficacy of inclisiran for individuals with ASCVD and those at cardiovascular disease risk, whose cholesterol levels remain inadequately controlled. The safety profile shows no new concerns emerging during this extended follow-up period. It recognizes the unmet clinical needs of patients and the necessity for clinical community assurance with any novel therapy.