EAS 2021 A pooled data analysis of ORION-9, 10 and 11 showed no changes in hematological and immunological biomarkers in patients with ASCVD or risk equivalent treated with inclisiran over a treatment period of 540 days.
This pooled patient-level analysis of three phase 3 trials (ORION-9, -10 and -11) shows that inclisiran reduces LDL-c on average by 50.7% compared to placebo in patients on maximally tolerated statin-therapy.
Experts in dialogue In this video, prof. Mach and prof. Stroes answer the question: How are we performing in Europe with regard to LDL-c goal attainment in very high risk patients?
Inclisiran has received approval from the European Commission (EC) for the treatment of adult patients with atherosclerotic CVD (ASCVD), ASCVD-risk equivalent and heterozygous FH.
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.