Novartis reports positive late-stage results for Leqvio in atherosclerotic CVD

Novartis has announced promising top-line results from a phase 3 clinical trial evaluating its drug Leqvio (inclisiran) as a standalone treatment for patients who are at risk of developing atherosclerotic cardiovascular disease (ASCVD). The V-MONO trial has been assessing the efficacy of this small interfering RNA (siRNA) therapy against both placebo and ezetimibe in patients who are at low or moderate risk for ASCVD and are not currently receiving other lipid-lowering treatments.

The trial successfully met its main objectives, demonstrating that Leqvio monotherapy was more effective than both placebo and ezetimibe in reducing low-density lipoprotein cholesterol (LDL-C) levels. Cardiovascular diseases, such as coronary heart disease and stroke, are the leading causes of death worldwide, according to the World Health Organization. ASCVD is responsible for 85% of all cardiovascular deaths and results from the buildup of plaques in the arterial walls, primarily comprising LDL-C.

Leqvio has already received approval in nearly 100 countries. It is designed to lower blood LDL-C levels and is administered as a subcutaneous injection by a healthcare provider. The treatment regimen involves an initial dose, a follow-up dose at three months, and subsequent doses every six months. This bi-annual schedule aims to improve patient adherence to treatment, which is often a challenge in managing cholesterol levels.

Shreeram Aradhye, president, development and chief medical officer at Novartis, expressed pride in the company's continued progress in using siRNA therapy to address significant healthcare challenges. He noted that many patients still struggle to achieve their cholesterol targets, and this trial contributes to the growing evidence supporting Leqvio across various ASCVD risk profiles. He emphasized the company's commitment to helping more patients in need.

Novartis plans to present the trial results at an upcoming medical conference and to share the data with regulatory bodies, including the US Food and Drug Administration. The company acquired the global rights to develop, manufacture, and commercialize Leqvio through a licensing and collaboration agreement with Alnylam Pharmaceuticals. Novartis is also advancing several other studies to evaluate the potential use of Leqvio for both primary and secondary prevention of cardiovascular events.