Results from phase 3 studies with Inclisiran, a potential first-in-class small interfering RNA (siRNA) agent, have shown that it is well-tolerated and provides effective and sustained reduction in low-density lipoprotein cholesterol (LDL-C) when used in addition to other lipid-lowering therapies regardless of patients’ age and gender.
Data presented at the recent American Heart Association Scientific Sessions 2020, showed pooled results from three ORION phase III trials in more than 3,600 patients with atherosclerotic cardiovascular disease (or heterozygous familial hypercholesterolemia (HeFH), who were given inclisiran at months 1, 3 and then every 6 months up to month 17.
Results of the first analysis showed LDL-C reductions of approximately 51% from baseline for both women and men at 17 months. A second analysis demonstrated treatment with inclisiran lowered LDL-C similarly by approximately 51% across three age groups (<65, ≥65 to <75, and ≥75 years old). In both analyses, inclisiran was well tolerated.
Inclisiran was given a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency in October 2020.