Amgen announced new data from its Phase 3 VESALIUS-CV clinical trial showing that Repatha (evolocumab) delivered statistically significant reductions in major adverse cardiovascular events among high-risk adults who had not previously experienced a heart attack or stroke. The findings establish Repatha as the first and only PCSK9 inhibitor demonstrated to significantly reduce the risk of first heart attack and stroke in high-risk primary prevention patients. The results were presented at the 2025 American Heart Association Scientific Sessions and published in the New England Journal of Medicine.
The global study included more than 12,000 patients with atherosclerosis or diabetes. It showed that adding Repatha to statins or other LDL-C–lowering therapies reduced the risk of coronary heart disease death, heart attack, or ischemic stroke by 25%. When assessing a broader composite endpoint that included any ischemia-driven arterial revascularization, Repatha achieved a 19% reduction. Repatha also reduced the risk of a heart attack alone by 36%. In a lipid sub-study, the median achieved LDL-C for patients on Repatha was 45 mg/dL compared to 109 mg/dL for patients receiving placebo.
The treatment showed meaningful benefit across multiple secondary endpoints, including reductions in combined risks involving heart attack, ischemic stroke, revascularization, and coronary heart disease death. Numerical trends also indicated reductions in cardiovascular death, coronary heart disease death, all-cause deat,h and ischemic stroke. Nearly 60% of patients in the trial had diabetes, and the results reinforced the importance of aggressively managing LDL-C to prevent first cardiovascular events in these patients.
No new safety concerns were reported. Tolerability was consistent with the current U.S. prescribing information, and only serious or discontinuation-related adverse events were collected during the trial.
VESALIUS-CV enrolled adults at high cardiovascular risk, including those with atherosclerotic cardiovascular disease or high-risk diabetes, who had no prior history of heart attack or stroke and elevated LDL-C levels despite optimized lipid-lowering therapy. Participants were followed for a median of approximately 4.6 years. The trial was designed to evaluate the effect of further LDL-C reduction with evolocumab on major adverse cardiovascular event outcomes.
Repatha has been available since 2015 and has been used by over 6.7 million patients worldwide. Earlier in the year, the U.S. Food and Drug Administration expanded the approved use of Repatha to include adults at increased risk for major cardiovascular events due to uncontrolled LDL-C. U.S. patients can access the therapy through Amgen’s direct-to-patient program at a monthly price of $239.
Amgen continues advancing research and treatment strategies aimed at reducing the burden of cardiovascular disease, which remains the leading cause of death worldwide. The company is pursuing multiple investigational therapies and collaborations focused on earlier detection, targeted treatment, and improved patient access.
KEY QUOTES:
“The VESALIUS-CV results deliver clear and compelling evidence that intensive LDL-C lowering is critical to reducing cardiovascular risk. 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.”
Jay Bradner, M.D., Executive Vice President of Research and Development, Amgen
“Building on the success of FOURIER, in which we showed that adding evolocumab to statin therapy in patients with a prior heart attack or stroke reduced the risk of subsequent major adverse cardiovascular events, we now show that in the much larger population of patients with atherosclerosis or diabetes, but without a prior heart attack or stroke, that adding evolocumab to their lipid regimen substantially reduces their risk of MACE. In both FOURIER and VESALIUS-CV, patients in the evolocumab arm achieved median LDL-C levels in the range of approximately 30 to 45 mg/dL, supporting such a target across a broad range of patients.”
Marc S. Sabatine, M.D., M.P.H., Chair of the TIMI Study Group and Lewis Dexter, MD, Endowed Chair in Cardiovascular Medicine, Brigham and Women’s Hospital
“Cardiovascular disease remains the leading cause of mortality and morbidity for people living with diabetes, driven by risk factors including high LDL-C. Reducing this risk needs to be prioritized in primary care settings where the majority of people living with diabetes receive care. The American Diabetes Association is committed to transforming diabetes care through the implementation of evidence-based guidelines for managing hyperlipidemia and reducing cardiovascular risk.”
Osagie Ebekozien, M.D., M.P.H., CPHQ, Chief Quality Officer, American Diabetes Association
