Phase III ORION-9, -10 and -11 trials of Leqvio show efficacy in atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.- Novartis

Novartis announced results from two pooled post-hoc analyses of Phase III ORION-9, -10 and -11 trials, evaluating the impact of age and gender on the efficacy and safety of Leqvio (inclisiran), an investigational and potential first-in-class small interfering RNA (siRNA) for hyperlipidemia in adults with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). The data showed that at month 17, inclisiran was well-tolerated and provided 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. During the trials, inclisiran was administered at months 1, 3 and then every 6 months up to month 17. In post-hoc analyses of the pooled results from the ORION Phase III trials in more than 3,600 patients, treatment with inclisiran delivered similar LDL-C reductions of approximately 51% from baseline for both women and men (50.6% vs 50.6% respectively) compared to placebo1. Results from a second pooled analysis showed that inclisiran-treated patients in three age categories all achieved similar LDL-C reductions of approximately 51% (?51.3% <65 years 49.9 at least 65 years to><75 years 51.0 at least 75 years. in both analyses inclisiran was well-tolerated. results were presented at the virtual american heart association scientific sessions 2020.on friday october 16 2020 the committee for medicinal products for human use of the european medicines agency adopted a positive opinion and recommended granting marketing authorization for inclisiran. novartis is anticipating a final regulatory decision in europe in december 2020 and is under review by the us food and drug administration.>