Novartis presents new long-term Leqvio data

Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly dosing, Leqvio, in addition to statin therapy, provides consistent low-density lipoprotein cholesterol reduction beyond six years in patients with atherosclerotic cardiovascular disease, ASCVD, increased risk of ASCVD or heterozygous familial hypercholesterolemia, HeFH. The results were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress 2023 in Amsterdam. ORION-8, the largest clinical trial completed to date with Leqvio, continues to support the consistent long-term efficacy, safety, and tolerability of Leqvio, with a total exposure of more than 8,500 patient-years during the trial’s three-year follow-up. Patients from four previous completed Novartis trials received Leqvio every six months for up to an additional three years. Nearly 80% of patients reached their pre-specified LDL-C targets, and on average, LDL-C levels were reduced by approximately 50%. These results demonstrate consistent efficacy as they are comparable to the LDL-C reductions observed at the end of the initial trials.