Novartis Submits Inclisiran, a First-in-Class siRNA Cholesterol-Lowering Therapy, for Clinical Trial Approval in China

By Baihuawen

On June 28, Novartis’ clinical trial application for Inclisiran injection in China was accepted by the Center for Drug Evaluation (CDE). This drug is a first-in-class small interfering RNA (siRNA) cholesterol-lowering agent acquired by Novartis through its $9.7 billion purchase of The Medicines Company, requiring only twice-yearly subcutaneous administration. Novartis has already submitted marketing applications for Inclisiran to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Three phase III clinical trials (ORION-9, 10, and 11) published in the NEJM demonstrated that, compared with placebo, twice-yearly subcutaneous injections of inclisiran following two initial doses resulted in sustained and significant reductions in LDL-C. Inclisiran was well tolerated, with a safety profile similar to that of placebo.

Source: NextPharma

Worldwide, more than 50 million patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) who are undergoing secondary prevention fail to achieve their low-density lipoprotein cholesterol (LDL-C) targets with existing standard therapies and remain at elevated risk for cardiovascular events. Inclisiran, administered via subcutaneous injection only twice a year, can significantly and durably lower LDL-C levels, enhance patient adherence to treatment, and help maintain consistently low cholesterol levels.