Novartis Announces Positive Phase 3 ORION-8 Data Showing Sustained LDL-C Reduction with Leqvio for Over Six Years

▎WuXi

Edited by Kant Content Team

Novartis today announced new long-term data from its Phase 3 ORION-8 clinical trial. The data indicate that,Its RNAi therapy Leqvio (inclisiran), administered twice yearly in combination with statin therapy, has been shown to sustainably reduce low-density lipoprotein cholesterol (LDL-C) for over six years in patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents, or heterozygous familial hypercholesterolemia (HeFH).Detailed results were presented at the European Society of Cardiology (ESC) Congress 2023.

Over time, atherosclerotic lesions develop gradually due to the accumulation of lipids, with low-density lipoprotein cholesterol (LDL-C) in the arterial walls being the primary culprit. The sudden rupture of an atherosclerotic plaque can lead to atherosclerotic cardiovascular events, such as heart attacks or strokes. Events caused by atherosclerotic cardiovascular disease (ASCVD), including heart attacks and strokes, account for 85% of all cardiovascular disease-related deaths. Many patients with elevated LDL-C levels also suffer from other conditions, such as hypertension, obesity, or diabetes, which significantly increase their risk of developing ASCVD and experiencing cardiovascular events.

Leqvio is an RNAi therapy targeting PCSK9 protein mRNA,As a prescription drug for injection, it is used as an adjunct to diet and statin therapy to treat adult patients with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia, to reduce LDL-C levels. Leqvio was initially approved by the US FDA in December 2021. The press release noted that it is the first small interfering RNA (siRNA) therapy capable of lowering LDL-C.

Results from the ORION-8 open-label extension trial showed that, in addition to statin therapy,Twice-yearly Leqvio treatment sustained reduction of low-density lipoprotein cholesterol through six years, with 8/10 patients reaching goal LDL-C threshold, consistent with previously reported phase 3 data.Long-term safety data are consistent with previous results, confirming that Leqvio therapy has a well-established and favorable safety profile.

References:

[1] Novartis presents new long-term Leqvio® (inclisiran)data demonstrating consistent efficacy and safety beyond six years. Retrieved August28, 2023 from https://www.novartis.com/news/media-releases/novartis-presents-new-long-term-leqvio-inclisiran-data-demonstrating-consistent-efficacy-and-safety-beyond-six-years