Amgen has announced new findings showing Repatha (evolocumab) reduced the risk of death by 20% in high-risk adults without a prior heart attack or stroke when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments.
The results come from a pre-specified analysis of the Phase 3 VESALIUS-CV trial that included more than 12,000 high-risk patients. Treatment with Repatha resulted in meaningful reductions both in overall deaths and cardiovascular deaths. The reduction in deaths began to appear after approximately 1.5 years of treatment and continued through a median follow-up of 4.6 years.
According to Amgen, by helping prevent major cardiovascular events, including heart attacks and strokes, Repatha may help extend life by reducing the risk of serious health decline following these events, thereby contributing to fewer deaths overall.
“For people at high risk of a heart attack or stroke, lowering LDL-C or ‘bad’ cholesterol with Repatha may do more than help prevent these events; it may also reduce the risk of dying from heart disease and its serious consequences,” said Jay Bradner, executive vice president, Research and Development, Artificial Intelligence and Data at Amgen.
“This is especially significant given cardiovascular disease remains the leading cause of death worldwide. The totality of these data is practice-changing and reinforces the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha,” he added.
Amgen also presented findings from two global real-world studies highlighting persistent gaps between guideline recommendations and everyday lipid management.
One study found that patients with coronary artery disease who had no prior heart attack or stroke were frequently undertreated and did not achieve recommended LDL-C levels, reflecting low rates of treatment initiation, treatment intensification and monitoring.
The second study highlighted sex-based disparities in cardiovascular care. It found that women at high risk, but without a prior heart attack or stroke, were less likely than men to receive intensive lipid-lowering treatment or achieve recommended LDL-C targets across different regions.
Amgen said the findings underscore the need for earlier and more intensive lipid-lowering treatment to help reduce the risk of a first major cardiovascular event.
Repatha was first approved in 2015 and has since been used by approximately nine million patients globally.
Repatha was first approved in 2015 and has since been used by approximately nine million patients globally.
In August 2025, the US Food and Drug Administration (FDA) expanded the approved use of Repatha to include adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL-C.
In August 2026, the European Commission approved an expanded indication for Repatha in adults with established or high-risk atherosclerotic cardiovascular disease (ASCVD) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to the correction of other risk factors. The expanded indication was supported by results from the Phase 3 VESALIUS-CV trial.
Repatha is approved in 75 countries, including the US, Japan, Canada and the 28 countries of the European Union. Applications in other countries are pending.
