Thousand Oaks, California, United States, November 9, 2026
Amgen has announced new clinical and health economic findings at the American Heart Association (AHA) Scientific Sessions 2026, highlighting the potential value of earlier treatment with Repatha (evolocumab) in patients at high risk of cardiovascular disease. The newly presented data strengthen the evidence supporting intensive low-density lipoprotein cholesterol (LDL-C) reduction in patients with and without a previous heart attack or stroke. The findings include an independent health economic analysis of the Phase III VESALIUS-CV trial, additional research involving patients with chronic kidney disease (CKD), and long-term effectiveness data from the FOURIER clinical development program. According to Amgen, the latest analyses demonstrate that Repatha can provide meaningful cardiovascular benefits across different high-risk patient populations. The findings support the importance of addressing elevated LDL cholesterol earlier in the cardiovascular risk continuum, rather than waiting until patients experience a major cardiovascular event. These results add to the growing clinical evidence supporting PCSK9 inhibition as an important approach to managing cardiovascular risk.
VESALIUS-CV Analysis Highlights Cost-Effectiveness
One of the major findings presented at AHA 2026 was an independent health economic analysis using individual participant-level data from the Phase III VESALIUS-CV clinical trial. The analysis was led by the Duke Clinical Research Institute in collaboration with the TIMI Study Group at Mass General Brigham and Harvard. Researchers evaluated the relationship between treatment costs and projected health benefits among high-risk patients without a previous heart attack or stroke. The findings indicated that Repatha was highly cost-effective, with its estimated cost-effectiveness approximately 36% below the American College of Cardiology and American Heart Association (ACC/AHA) benchmark. A separate analysis also found that adding Repatha to standard therapy was highly cost-effective compared with standard therapy alone in adults with established atherosclerotic cardiovascular disease (ASCVD). These findings are particularly relevant because cardiovascular disease prevention requires effective long-term management of cholesterol and other risk factors. The VESALIUS-CV study previously demonstrated a 25% relative reduction in the risk of coronary heart disease death, heart attack or ischemic stroke with evolocumab. It also reported a 19% reduction in a broader composite cardiovascular endpoint and a 36% reduction in heart attack risk. The latest economic findings provide additional evidence supporting the potential value of earlier LDL-C lowering in high-risk patients.
Repatha Shows Cardiovascular Benefits in Kidney Disease
Amgen also presented a prespecified analysis of VESALIUS-CV evaluating patients with chronic kidney disease who had no previous heart attack or stroke. The analysis demonstrated that patients with CKD experienced substantially higher cardiovascular risk than those without the condition, with approximately 90% higher rates of coronary heart disease death, heart attack or ischemic stroke. Over a median follow-up period of 4.6 years, Repatha treatment was associated with a 39% reduction in three-point major adverse cardiovascular events (3-point MACE) among patients with CKD. The analysis also reported a 23% reduction in four-point MACE, which additionally included ischemia-driven arterial revascularization, and a 29% reduction in the risk of all-cause death. These findings highlight the importance of cardiovascular risk management in patients with kidney disease, who frequently experience multiple interconnected metabolic and cardiovascular complications. The company also presented long-term effectiveness findings from an analysis combining data from the FOURIER trial and its open-label extension. Researchers compared treated patients with a non-randomized external control group derived from UK health records. Over a maximum follow-up period exceeding eight years, Repatha treatment was associated with a 29% lower rate of three-point MACE and a 25% lower risk of cardiovascular death. Although these long-term findings are based on an external-control comparison rather than a randomized comparison throughout the entire follow-up period, they provide additional evidence about the durability of cardiovascular outcomes.
Repatha’s Mechanism and Expanding Clinical Evidence
Repatha (evolocumab) is a fully human monoclonal antibody and PCSK9 inhibitor developed by Amgen to reduce LDL cholesterol levels and cardiovascular risk. It works by binding to proprotein convertase subtilisin/kexin type 9 (PCSK9), preventing the protein from promoting the degradation of LDL receptors on liver cells. This allows more LDL receptors to remain available to remove LDL cholesterol from the bloodstream. The medicine is administered through subcutaneous injection and is approved for several cholesterol-management and cardiovascular risk-reduction indications. The Phase III FOURIER trial previously demonstrated a 59% reduction in LDL-C levels, from a median baseline of 92 mg/dL to 30 mg/dL. The trial also showed a significant reduction in major cardiovascular events among patients with established ASCVD. Repatha has received regulatory approvals in multiple countries, and its clinical development program includes extensive research involving different cardiovascular risk populations. The latest AHA 2026 presentations further expand the evidence supporting its use in appropriate high-risk patients. Amgen’s findings emphasize the importance of earlier cholesterol management, long-term cardiovascular prevention and improved access to effective lipid-lowering therapies. The new findings presented at AHA 2026 represent an important addition to Amgen’s cardiovascular research program. Evidence from VESALIUS-CV, FOURIER and their subsequent analyses reinforces the clinical importance of LDL-C reduction across different patient populations. The results strengthen the scientific case for earlier cardiovascular risk management with Repatha, while highlighting the continuing importance of clinical research in improving long-term cardiovascular outcomes.
Source: Amgen press release



