New Novartis data show early addition of twice-yearly* Leqvio (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting - Seite 3

*After an initial dose and another at three months.

About Leqvio
Leqvio is a subcutaneous injection given by a health care provider (HCP) with an initial dose, another at three months, and then every six months^2,5. As a twice-yearly, HCP-administered treatment, Leqvio may help to circumvent the challenges of treatment adherence, a common issue in cholesterol management. Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 90 countries, including the U.S., EU, Japan and China^1,5,6.

Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

About V-INITIATE
V-INITIATE is a 12-month, randomized, multicenter, open-label Phase IIIb study in 450 atherosclerotic cardiovascular disease (ASCVD) patients in the U.S. with elevated LDL cholesterol (LDL-C) ≥70 mg/dL. The study evaluated the effectiveness of adding HCP-administered Leqvio earlier, following a patient’s failure to reach LDL-C goal on maximally tolerated statin therapy, compared to usual care¹. Usual care was determined by the clinicians and based on the 2018 American College of Cardiology/American Heart Association guideline recommendations; most patients (73%) in the usual care arm remained on statins only¹. The co-primary endpoints were the percentage change in LDL-C from baseline to Day 330 and the discontinuation of statin therapy, defined as no statin use ≥30 days before the end of study visit¹. This is the first Novartis trial where all patients have been tokenized with the intention of following their outcomes for two additional years post-trial completion, providing additional insights on the real-world effectiveness of Leqvio⁷.

About VictORION
The V-INITIATE trial is part of VictORION, an innovative and robust clinical program for Leqvio, comprising more than 30 trials and enrolling over 60,000 patients in more than 50 countries worldwide⁷. The program is designed to expand on the foundational evidence of LDL-C reduction with Leqvio in diverse patient populations to include randomized clinical trials, implementation research, real-world evidence, and trials that aim to establish its potential benefits on cardiovascular outcomes in primary and secondary prevention. A growing number of studies are planned to generate a vast array of data with major trials such as ORION-4 (secondary prevention), V(VictORION)-2-PREVENT (secondary prevention), V-1-PREVENT (high-risk primary prevention), V-INCEPTION and V-MONO.