Thousand Oaks, Calif. – August 31, 2026
Amgen announced new Phase 3 findings showing that Repatha® (evolocumab) reduced the risk of death by 20% in adults at high risk for a first heart attack or stroke who had no previous myocardial infarction or stroke. The results came from a prespecified analysis of the VESALIUS-CV Phase 3 trial, which enrolled more than 12,000 high-risk patients receiving Repatha or placebo alongside optimized lipid-lowering therapy. Presented during a late-breaking science session at the European Society of Cardiology (ESC) Congress 2026 in Munich and simultaneously published in Circulation, the findings add an important mortality dimension to the clinical evidence supporting intensive LDL-C reduction in high-risk primary prevention patients. The mortality benefit began to emerge after approximately 1.5 years of treatment and continued through a median follow-up of 4.6 years, reinforcing the potential importance of sustained LDL-C lowering before a first major cardiovascular event occurs.
Amgen Reports Repatha Mortality Benefit in VESALIUS-CV
The latest analysis represents a significant development for Repatha, because it showed reductions in both all-cause mortality and cardiovascular mortality among patients who had not previously experienced a heart attack or stroke. VESALIUS-CV was specifically designed to evaluate whether intensive LDL-C lowering with evolocumab could reduce major cardiovascular events in adults at elevated cardiovascular risk. Participants had established atherosclerotic cardiovascular disease or high-risk diabetes but no prior myocardial infarction or stroke, and entered the study with elevated LDL-C, non-HDL-C or apolipoprotein B despite background lipid-lowering treatment. The new mortality findings suggest that preventing major cardiovascular events may translate into a broader survival benefit in this population. Importantly, the company emphasized that the reduction in deaths developed progressively during follow-up rather than immediately after treatment initiation, highlighting the potential value of early and persistent LDL-C management in patients who remain at substantial cardiovascular risk.
Repatha Shows Broader Cardiovascular Protection
Additional analyses from VESALIUS-CV further strengthened the cardiovascular findings surrounding evolocumab. Repatha reduced the risk of first, subsequent and total cardiovascular events, with the reduction in subsequent events contributing substantially to the overall number of events prevented during the trial. A separate prespecified analysis also found that the reduction in first myocardial infarction became evident as early as approximately six months after treatment initiation. The benefit was primarily associated with fewer heart attacks caused by type 1 myocardial infarction, including events related to atherosclerotic plaque rupture, as well as larger infarctions. Across these analyses, treatment effects remained consistent across key patient subgroups. Earlier VESALUS-CV findings showed that Repatha reduced the risk of the trial’s three-component major cardiovascular endpoint by 25% and the broader four-component endpoint by 19%, while myocardial infarction risk was reduced by 36%. Together, the data support the role of intensive LDL-C lowering in reducing cardiovascular events before patients experience their first major event.
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Amgen Highlights Persistent LDL-C Treatment Gaps
Alongside the clinical trial findings, Amgen presented global real-world analyses highlighting persistent gaps between recommended lipid management and treatment in everyday clinical practice. One analysis found that patients with coronary artery disease who had not experienced a previous heart attack or stroke were frequently undertreated and failed to reach recommended LDL-C targets, reflecting gaps in treatment initiation, treatment intensification and ongoing monitoring. Another analysis identified differences in lipid management between men and women, with high-risk women less likely than men to receive intensive lipid-lowering treatment and achieve LDL-C goals across multiple regions. These real-world findings provide an important clinical context for the VESALIUS-CV mortality results, as many high-risk patients continue to have residual cardiovascular risk because LDL-C levels remain above recommended targets. Repatha, a PCSK9 inhibitor, lowers LDL-C by preventing PCSK9 from promoting degradation of LDL receptors in the liver, thereby increasing LDL-C clearance from the bloodstream. Amgen said the combined evidence reinforces the need to identify high-risk patients earlier and pursue effective, sustained lipid management to reduce cardiovascular morbidity and mortality.
Source:Amgen press relese
