Novartis Presents Positive Results for Leqvio in V-DIFFERENCE Study at ESC Congress

Novartis announced positive results from the Phase IV V-DIFFERENCE study, evaluating Leqvio (inclisiran) versus placebo in patients with high cholesterol. The study showed that 85% of patients treated with Leqvio plus lipid-lowering therapy achieved LDL-C goals within 90 days, compared to 31% on placebo plus LLT. Patients on Leqvio also experienced a 43% reduction in muscle-related adverse events. The results highlight Leqvio's potential to transform cardiovascular care and improve meaningful outcomes for patients.

Novartis has announced positive results from the Phase IV V-DIFFERENCE study, which evaluated Leqvio (inclisiran) versus placebo in patients with high cholesterol (hypercholesterolemia) who did not achieve guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals [1].

The study, presented during one of the Hot Line sessions at the 2025 European Society of Cardiology (ESC) Congress in Madrid, Spain, from August 29 to September 1, 2025, showed that 85% of patients treated with Leqvio plus individually optimized lipid-lowering therapy (LLT) achieved their LDL-C goals within 90 days, compared to 31% of patients on placebo plus LLT [1, 2]. Additionally, patients on Leqvio plus LLT were 43% less likely to experience muscle-related adverse events compared to those on placebo plus LLT [1, 2].

Ulf Landmesser, M.D., Chair of the Department of Cardiology, Angiology and Intensive Care Medicine at the German Heart Center Charité and Charité University Medical Center Berlin, stated that V-DIFFERENCE is the largest study of LDL-C reduction with Leqvio to date and the first to focus on patient-centered outcomes. He highlighted that the results demonstrate the potential of Leqvio to transform cardiovascular care by improving meaningful outcomes for patients [1].

Ruchira Glaser, M.D., Global Head of Cardiovascular, Renal and Metabolism Development at Novartis, emphasized that early use of Leqvio is an effective way to help patients reach their LDL-C goals faster without the need to add additional treatments or maximize statin doses [1, 2].

Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is a subcutaneous injection given by a healthcare provider (HCP) with an initial dose, another at three months, and then every six months [2]. The study results add to the growing body of evidence for Leqvio within the VictORION clinical program, which encompasses more than 60,000 patients from 50 countries worldwide [2].

The V-DIFFERENCE study, part of the VictORION clinical trial program, is significant as it demonstrates effective options for lipid management improvement in patients at risk, a majority of whom continue to remain above recommended LDL-C levels [2]. The study also evaluated the effect of Leqvio on muscle symptoms and pain, which are common amongst patients receiving statins and other LLT [2].

These findings underscore the potential of Leqvio to enhance cardiovascular care and improve patient outcomes. The results will be crucial in guiding clinical decisions and shaping future treatment strategies for hypercholesterolemia.

References:
[1] https://www.marketscreener.com/news/novartis-presents-results-for-leqvio-at-esc-ce7c50d2dc8dfe27
[2] https://finance.yahoo.com/news/novartis-leqvio-shows-statistically-significant-150000066.html