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Repatha is the First and Only PCSK9 Inhibitor Shown to Lower the Risk of Dying from All Causes, Including Cardiovascular Events, in High-Risk Primary Prevention Patients in a Phase 3 Trial
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Separate Global Real-World Analyses Show Persistent Gaps in Lipid Management, With Many High-Risk Patients Undertreated and Not Achieving Recommended LDL-C Goals
THOUSAND OAKS, Calif., Aug. 31, 2026 /PRNewswire/ --Amgen(NASDAQ: AMGN) today announced new findings showing Repatha® (evolocumab) reduced the risk of death 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 are from a pre-specified analysis of the Phase 3 VESALIUS-CV trial and were presented in a late-breaking science session at theEuropean Society of Cardiology (ESC) Congress2026 inMunich, Germany. They were also simultaneously published in Circulation.
In a study of more than 12,000 high-risk patients, Repatha helped reduce the risk of dying by 20%. Treatment with Repatha led to meaningful reductions both in overall deaths and cardiovascular deaths in this pre-specified secondary analysis of VESALIUS-CV. By helping prevent major cardiovascular events, such as heart attacks and strokes, Repatha may extend life by helping patients avoid the serious health decline that can follow, contributing to fewer deaths overall. 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.
"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," saidJay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data atAmgen. "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."
Additional VESALIUS-CV and Real-World Analyses Reinforce the Need for Earlier, Intensive LDL-C Lowering in High-Risk Patients
The mortality findings were accompanied by two additional VESALIUS-CV analyses. One analysis showed that Repatha reduced the risk of first, subsequent and total CV events. The other analysis showed that the reduced risk of heart attack with Repatha was seen as early as six months after initiating treatment. The reduction in risk was primarily driven by a decrease in heart attacks caused by a rupture of atherosclerotic plaque (type 1) and larger infarctions. In both analyses, benefits were consistent across key patient subgroups, adding to the growing body of evidence supporting the importance of earlier LDL-C lowering with Repatha in high-risk patients.
"These analyses reinforce that a patient's first major cardiovascular event is not merely an isolated occurrence, but often a transition to a higher risk state," saidMarc S. Sabatine, M.D., M.P.H., Chair of theTIMI Study Groupand theLewis Dexter, MD, Endowed Chair in Cardiovascular Medicine atMass General Brigham Heart & Vascular Institute. "Evolocumab reduced not only first cardiovascular events, but also subsequent events during the course of the study, the latter of which almost doubled the number of events prevented. By preventing these events, evolocumab can alter the patient's trajectory, with lower rates of all-cause mortality and consistent effects for both cardiovascular and non-cardiovascular mortality. Together, these data support the large clinical benefit of intensive LDL-C lowering with evolocumab down to ~40 mg/dL to help prevent cardiovascular morbidity and mortality."
Amgenalso presented results 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 and no prior heart attack or stroke were often undertreated and did not achieve recommended LDL-C levels, reflecting low rates of treatment initiation, intensification and monitoring.
The second study highlighted disparities observed in cardiovascular care between sexes, showing that women at high risk with no prior heart attack or stroke were less likely than men to receive intensive lipid-lowering treatment and achieve LDL-C goals across regions. These studies underscore an urgent need for timely, more intensive lipid-lowering treatment to help reduce the risk of a first major cardiovascular event.
For more information about the data presented at ESC, see below:
AmgenAbstracts
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Effects of Evolocumab on Fatal Outcomes in Patients Without a Prior Myocardial Infarction or Stroke: Pre-specified Analysis of the VESALIUS-CV Trial Abstract #87624, Monday, August 31 from 9:15 - 9:30 a.m. CEST
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Sex Differences in Lipid Management Among High-Risk Patients Without Prior Myocardial Infarction or Stroke: Results from the VESALIUS-REAL Global Study Abstract #83602, Monday, August 31 from 12:10 - 12:20 p.m. CEST
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Real World Evaluation of Lipoprotein (a) Testing and Impact on Lipid Management in Atherosclerotic Cardiovascular Disease Patients: Findings from the CVMOBIUS2 Registry Abstract #82835, Presented Sunday, August 30
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Reduction in Total Cardiovascular Events with Evolocumab in Patients with No Prior Myocardial Infarction or Stroke: A Pre-Specified Analysis of VESALIUS-CV Abstract #85353, Presented Saturday, August 29
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Lipid Management in Patients with Coronary Artery Disease at Risk of a First Major Atherosclerotic Cardiovascular Event: Findings from the VESALIUS-REAL Global Study Abstract #83605, Presented Saturday, August 29
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Evolocumab and Risk of a First Myocardial Infarction: A Pre-Specified Analysis of the VESALIUS-CV Trial Abstract #87346, Presented Friday, August 28
Investigator-Sponsored Studies (ISS)
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AMUNDSEN: Evolocumab Before Percutaneous Coronary Intervention for Acute Myocardial Infarction Abstract #7002, Presented Saturday, August 29
About the VESALIUS-CV Trial
VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Results were published in the New England Journal of Medicine inNovember 2025. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a lipid sub-study, adding Repatha to a maximally tolerated dose of statin and/or ezetimibe substantially lowered LDL-C levels among observed patients, with a median level of 45 mg/dL compared to 109 mg/dL in the placebo group.
VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on local lab testing. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.
About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.3 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.4 Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintaining dramatic LDL-C reductions using Repatha once every two weeks.5,6
Repatha was first approved in 2015 and has since been used by approximately 9 million patients globally.7 InAugust 2025, theU.S. Food and Drug Administrationbroadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. InAugust 2026, theEuropean Commissionapproved an expanded indication for the use of Repatha in adults with established or high risk for ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors, based on results from the Phase 3 VESALIUS-CV trial. Repatha is approved in 75 countries, including theU.S.,Japan,Canadaand in all 28 countries that are members of the European Union.8 Applications in other countries are pending.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
REFERENCES
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Eroglu T, Capone F, Schiattarella GG. The evolving landscape of cardiometabolic diseases. EBioMedicine. 2024 Nov;109:105447. doi: 10.1016/j.ebiom.2024.105447. Epub 2024 Nov 4. PMID: 39500010; PMCID: PMC11570325.
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Tan SH, Wu JL, Zhuo SX, Zhang Y, Wang M. Residual risk in atherosclerotic cardiovascular disease after statin therapy: Clinical mechanisms and management strategies. World J Cardiol. 2026 Feb 26;18(2):114960. doi: 10.4330/wjc.v18.i2.114960. PMID: 41694036; PMCID: PMC12897005.
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Data on File; Amgen, 2025.
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Data on File; Amgen, 2025.
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Ndumele, C. E., & Blumenthal, R. S. (2025). VESALIUS and the Anatomy of High-Risk Prevention. New England Journal of Medicine. https://doi.org/10.1056/nejme2515447
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Marston, N. A., Bohula, E. A., Bhatia, A. K., et al. (2026). Evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: Results from the VESALIUS‑CV trial. JAMA. https://doi.org/10.1001/jama.2026.3277
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Data on File. Amgen, 2026.
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Data on File; Amgen, 2025.