Amgen announces data on Repatha from Phase 3 Vesalius-CV trial

Amgen (AMGN) announced that Repatha, when added to statins or other low-density lipoprotein cholesterol-lowering treatments, reduced the risk of first major adverse cardiovascular events in high-risk primary prevention patients without known significant atherosclerosis and with diabetes. The findings were presented in a late-breaking session at the American College of Cardiology 75th Annual Scientific Session and simultaneously published in the Journal of the American Medical Association. The results are from a new subgroup analysis of 3,655 patients at increased risk of CV events without known significant atherosclerosis followed for a median of 4.8 years from the Phase 3 VESALIUS-CV clinical trial. Results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction or ischemic stroke by 31% compared with placebo. Repatha also reduced the risk of a dual composite primary endpoint that included ischemia-driven revascularization by 31%. The median achieved LDL-C was 44 mg/dL at 96 weeks in the Repatha added to optimized lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimized lipid-lowering therapy arm.