Novartis announces new data on twice-yearly Leqvio in ASCVD

Novartis announced new data demonstrating the early addition of twice-yearly Leqvio to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease, including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone. The late-breaking data were presented at the 2024 American College of Cardiology’s Annual Scientific Session & Expo and simultaneously published in the Journal of the American College of Cardiology. In the V-INITIATE study, patients receiving Leqvio experienced significant reductions in LDL-C compared to those receiving usual care, which consisted mostly of statin therapy alone. Four in five patients receiving Leqvio achieved the guideline-recommended LDL-C goal of less than70 mg/dL compared to just one in five patients receiving usual care. Notably, patients receiving health care provider-administered Leqvio maintained adherence to existing lipid-lowering therapy, and the discontinuation rate of background statin therapy did not differ between the Leqvio and usual care arms. The safety results from V-INITIATE were consistent with findings from the pivotal Phase III clinical trial program and long-term open-label extension trials, ORION-3 and ORION-8, which demonstrated sustained safety for up to six years of treatment.