The FDA has approved the small interfering RNA (siRNA) PCKS9 therapy inclisiran to lower LDL-c with two doses a year, after a first dose and one at 3 months, for treatment of adults with clinical ASCVD or FH.
Real-world evidence shows that the majority of patients do not achieve their LDL-c target goals. Where do we fall short in the need for combination therapy?
The new therapeutic options for LDL-c lowering, bempedoic acid and inclisiran, are discussed by prof. Ballantyne. How do these drugs lower LDL-c and what are the findings in phase III programs?
The NHS has made an agreement on a population health management approach in those eligible for the PCSK9 siRNA inclisiran.
ESC 2021 This pooled, post-hoc analysis of ORION-9, -10, and -11 showed that inclisiran significantly reduced LDL-c compared placebo in patients with and without polyvascular disease.
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.