Novartis shares positive real-world data for Leqvio in atherosclerotic CVD

LDL-C is a causal risk factor for ASCVD and increases the risk of heart disease and stroke. 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.

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.

April 12, 2024