Following the results from the ORION program, the CHMP of EMA has issued a positive opinion on inclisiran to reduce LDL-c in patients with hypercholesterolemia or mixed dyslipidemia.
EAS 2020 In a cohort of high-risk primary prevention individuals, 6-monthly injections with inclisiran reduced LDL-c and other atherogenic lipoproteins compared to placebo.
EAS 2020 A subanalysis of ORION-9 showed that lowering of LDL-c by inclisiran was similar across subgroups of genotypes in those with heterozygous FH.
Inclisiran, an siRNA against PCSK9, did not result in adverse effects on measures of inflammation, immune activation and platelets. No clinical immunogenicity AEs were observed.
AHA 2019 The siRNA ARO-APOC3 prevents production of APOC3 through RNA interference. It lowered levels of APOC3, TG and VLDL-c and increased HDL-c, and was well tolerated.
AHA 2019 The ORION-10 trial met all its primary and secundary efficacy endpoints, with a good safety profile, up to 17 months.
AHA 2019 The ORION-10 results showed LDL-c lowering of over 50% with inclisiran, an inhibitor of PCSK9 through RNA interference, with a safety profile similar to placebo.
Topline results of ORION-9 and ORION-10 showed durable and potent efficacy and safety of twice-yearly injections of inclisiran in HeFH patients and participants with ASCVD, respectively.
Prof. Kastelein discusses new strategies to target PCSK9, including twice-a-year injections of inclisiran and a newly developed oral PCSK9 inhibitor.
ESC 2019 Prof. John Kastelein shares the results of the phase 3 ORION-11 trial with inclisiran in ASCVD and risk equivalent patients not at LDL-C goal.
Phase 3 ORION-11 results up to 18 months show efficacy of inclisiran, which prevents production of the PCSK9 protein, consistent with earlier studies and an at least as favorable safety profile.
EAS 2019 The pilot ORION-2 study shows that inclisiran, an siRNA that prevents production of PCSK9, yielded persistent lowering of LDL-c levels up to 6 months in 3 out of 4 hoFH patients.