Amgen has reported positive results from its phase 3 VESALIUS-CV trial, which demonstrated that Repatha (evolocumab) significantly reduced the risk of first-time major adverse cardiovascular events (MACE) in adults at high cardiovascular risk.
The findings were presented during a late-breaking session at the 2025 American Heart Association (AHA) Scientific Sessions and published simultaneously in the New England Journal of Medicine (NEJM).
The landmark, randomised, placebo-controlled study enrolled approximately 12,000 patients with atherosclerosis or diabetes but no prior history of heart attack or stroke. Participants received Repatha in combination with statins or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies.
Repatha, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), is the first and only PCSK9 inhibitor to demonstrate a statistically significant reduction in cardiovascular events for both primary and secondary prevention populations, according to Amgen.
In VESALIUS-CV, treatment with Repatha led to statistically significant and clinically meaningful reductions in the composite risk of coronary heart disease death, myocardial infarction or ischaemic stroke. Secondary endpoints were also met, with trends indicating reduced mortality rates.
In the US, a heart attack or stroke occurs every 45 seconds, with around 75% of cases being first-time events. Globally, cardiovascular disease remains the leading cause of death.
“The VESALIUS-CV results deliver clear and compelling evidence that intensive LDL-C lowering is critical to reducing cardiovascular risk,” said Jay Bradner, executive vice president of Research and Development at Amgen.
“Repatha has once again demonstrated its ability to protect patients from the cardiovascular events they fear most, like heart attack or stroke, even before one occurs.
“These findings reinforce the urgent need to translate today’s evidence into tomorrow’s clinical practice. With a decade of real-world experience and proven benefit across the continuum of cardiovascular disease, every patient facing elevated risk due to uncontrolled LDL-C should be considered for Repatha.”
Repatha was first approved in 2015, and recent guidance from the US Food and Drug Administration (FDA) has expanded its indication to include adults at increased risk for major adverse cardiovascular events linked to uncontrolled LDL-C. The treatment is now available through Amgen’s direct-to-patient platform, AmgenNow, at a reduced price compared with its current US list price.