Novartis has shared new real-world data for its Leqvio (inclisiran) in reducing low-density lipoprotein cholesterol (LDL-C) in atherosclerotic cardiovascular disease (ASCVD) patients.
Published in the Journal of the American College of Cardiology, results from the V-INITIATE study were presented at the 2024 American College of Cardiology’s Annual Scientific Session and Expo.
Referring to a variety of diseases caused by the development and growth of plaques in the inner lining of the arteries, ASCVD can be caused by LDL-C, which can increase the risk of heart disease and stroke.
The 12-month, open-label study designed to more accurately represent the diversity of the US general population in clinical practice evaluated the effectiveness of adding Leqvio earlier, following a ASCVD patient’s failure to reach the LDL-C goal on maximally tolerated statin therapy versus standard care.
Results demonstrated a 60% reduction in LDL-C in patients receiving Leqvio compared to those receiving usual care (7%), while four in five patients receiving Leqvio achieved the guideline-recommended LDL-C goal of 70mg/dL or less compared to one in five receiving usual care.
The safety results of Leqvio were consistent with the phase 3 clinical trial programme and long-term open-label extension trials, ORION-3 and ORION-8, which demonstrated sustained safety for up to six years of treatment.
David Soergel, global head of cardiovascular, renal and metabolic drug development, Novartis, said: “This study adds data from a real-world setting to the growing body of evidence for Leqvio… and further reinforces the clinical value of this twice-yearly HCP-administered therapy.”
The primary investigator of the study, Michael Koren, medical director and chief executive officer, Jacksonville Center for Clinical Research, commented: “When added earlier in the treatment continuum, the structured use of… Leqvio… significantly reduced LDL-C for ASCVD patients who [were] struggling to reach or maintain their LDL-C goal.”
Already approved in over 90 countries, including the US, EU, Japan and China, Leqvio is the first and only small-interfering RNA therapy to lower LDL-C and helps to circumvent the challenges of treatment adherence in cholesterol management.
Novartis previously gained the global rights to develop, manufacture and commercialise Leqvio in 2022 under a license and collaboration agreement with Alnylam Pharmaceuticals.