Novartis' Leqvio: A New Hope For Lowering Cholesterol

Novartis' experimental drug, Leqvio (inclisiran), has shown promising outcomes in a Phase III clinical trial, significantly reducing low-density lipoprotein cholesterol (LDL-C) levels in patients with low to moderate risk of atherosclerotic cardiovascular disease (ASCVD). The V-MONO study assessed Leqvio as a standalone treatment, comparing its effectiveness to both a placebo and ezetimibe, a widely used cholesterol-lowering drug. 

Notably, participants in the trial were not on any existing lipid-lowering therapies. This study marks a breakthrough as Leqvio is the first small interfering RNA (siRNA) treatment tested for lowering LDL-C in this patient group. Novartis intends to submit the results to regulatory bodies, including the U.S. Food and Drug Administration (FDA), and share the findings at an upcoming medical conference.

Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis, said in a statement, “We are proud that we continue to advance the scientific understanding of using siRNA therapy to tackle one of the world’s biggest healthcare challenges, as too many people still struggle to reach their cholesterol goals. This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need.”

Novartis is actively exploring the broader potential of Leqvio through multiple ongoing studies aimed at assessing its benefits in both primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD). The VICTORION-1-PREVENT (V1P) trial is specifically targeting patients at high risk who require primary prevention, whereas the ORION-4 and VICTORION-2-PREVENT (V2P) studies are focused on evaluating the drug's effectiveness in secondary prevention scenarios.