Amgen, a global biopharmaceutical leader, announced new results from the Phase 3 VESALIUS-CV trial showing that Repatha (evolocumab) significantly lowers the risk of major cardiovascular events in high-risk adults who have not previously experienced a heart attack or stroke. Repatha, when added to statins or other LDL-C-lowering therapies, demonstrated both statistically significant and clinically meaningful reductions in major adverse cardiovascular events, or MACE. The study, presented at the 2025 American Heart Association Scientific Sessions and published in the New England Journal of Medicine, confirms that Repatha is the first PCSK9 inhibitor to show significant cardiovascular protection in both primary and secondary prevention populations.
The trial included over 12,000 patients with atherosclerosis or diabetes who had not suffered a prior heart attack or stroke. Repatha lowered the relative risk of a composite endpoint of coronary heart disease death, heart attack, or ischemic stroke by 25 percent and reduced a broader composite including ischemia-driven arterial revascularization by 19 percent. The treatment also cut the risk of heart attack by 36 percent. In a subset of patients in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo group.
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Jay Bradner, M.D., executive vice president of Research and Development at Amgen, said the findings highlight the importance of intensive LDL-C lowering to reduce cardiovascular risk. He emphasized that Repatha protects patients from serious events such as heart attack or stroke even before one occurs and stressed the need to implement these findings in clinical practice. With over ten years of real-world experience and proven benefits across cardiovascular disease, he stated that Repatha should be considered for every patient with elevated LDL-C who faces increased cardiovascular risk.
Repatha also produced significant reductions in secondary endpoints, including combinations of heart attack, ischemic stroke, and any ischemia-driven revascularization, as well as cardiovascular and coronary heart disease death. Trends toward lower mortality were observed, including 21 percent reduction in cardiovascular death, 11 percent reduction in CHD death, and 20 percent reduction in all-cause death, along with a 21 percent lower risk of ischemic stroke.
Marc S. Sabatine, M.D., M.P.H., Chair of the TIMI Study Group at Brigham and Women’s Hospital, noted that VESALIUS-CV builds on the earlier FOURIER trial, demonstrating that evolocumab added to statin therapy lowers MACE risk even in patients without prior heart attack or stroke. Patients in both studies achieved median LDL-C levels between 30 and 45 mg/dL, supporting the use of intensive LDL-C lowering across a broad range of high-risk individuals.
The trial also confirmed significant cardiovascular risk reduction in the nearly 60 percent of participants with diabetes, emphasizing the importance of managing LDL-C in this population. Osagie Ebekozien, M.D., M.P.H., CPHQ, Chief Quality Officer at the American Diabetes Association, highlighted that cardiovascular disease remains the leading cause of death for people with diabetes and stressed the need to implement evidence-based lipid management in primary care.
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No new safety concerns were identified, and tolerability remained consistent with the current U.S. prescribing information. Only serious or treatment-limiting adverse events were captured in the trial. Cardiovascular disease remains the leading cause of mortality worldwide, with heart attacks or strokes occurring every 40 seconds in the U.S., most of which are first-time events and associated with at least one modifiable risk factor such as high LDL-C.
Repatha, approved in 74 countries including the U.S., Japan, Canada, and the European Union, has been used by over 6.7 million patients globally. The FDA recently expanded Repatha’s approved use to adults at increased risk for MACE due to uncontrolled LDL-C. U.S. patients can access Repatha through AmgenNow, the company’s direct-to-patient program, at a monthly cost of $239, nearly 60 percent below the list price.
VESALIUS-CV is a global, double-blind, randomized, placebo-controlled Phase 3 trial evaluating LDL-C lowering with evolocumab in adults at high cardiovascular risk without previous heart attack or stroke. Patients included had atherosclerotic cardiovascular disease or high-risk diabetes with elevated LDL-C or other lipid parameters and were on the highest tolerated statin dose with or without ezetimibe. The median baseline LDL-C was 122 mg/dL. Participants received Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of 4.6 years.
Amgen continues to advance cardiovascular care through innovative therapies and strategic partnerships, targeting modifiable risk factors such as LDL-C, Lp(a), obesity, diabetes, and hypertension. Repatha is a fully human monoclonal antibody that inhibits PCSK9, preventing LDL receptor degradation and enabling the liver to remove more LDL from the blood. With over 15 years of clinical and real-world evidence, Repatha remains the most studied PCSK9 inhibitor, supporting cardiovascular risk reduction across diverse patient populations and care settings.
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