Amgen (NASDAQ: AMGN) reported positive top-line results from the Phase 3 VESALIUS-CV clinical trial, a historic study that showed Repatha® (evolocumab), its cholesterol-lowering drug, significantly lowers the risk of major adverse cardiovascular events (MACE) in high-risk adults who have never experienced a heart attack or stroke. These results position Repatha as the first and only PCSK9 inhibitor to demonstrate such a benefit in this patient population, marking a significant turning point in the prevention of cardiovascular disease.
More than 12,000 patients at high risk for cardiovascular events were enrolled in the VESALIUS-CV research, which achieved its two main goals. The research demonstrated a statistically and clinically significant decrease in the time to the first occurrence of a composite of heart attack, ischemic stroke, or coronary heart disease (CHD) mortality. For a more comprehensive composite endpoint that included encompassed any ischemia-driven arterial revascularization, a comparable effect was noted. Over a median follow-up of almost 4.5 years, the strong results were obtained, and no additional safety signs were noticed.
Many heart attacks and strokes are first-time occurrences, making cardiovascular disease a major worldwide health concern. The VESALIUS-CV trial shows that Repatha is effective in a primary preventive context for high-risk patients, thereby addressing a key unmet need. The fact that almost 85% of the research participants were already receiving high-intensity or moderate medication to lower low-density lipoprotein cholesterol (LDL-C) underscores the extra advantage of Repatha in this demographic.
As part of the “Groundbreaking Trials in Cardiometabolic Therapeutics” discussion at the American Heart Association Scientific Sessions on November 8, 2025, the complete findings from the VESALIUS-CV trial will be presented. Additionally, the data will be submitted to a peer-reviewed medical journal for publication.
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VESALIUS-CV Trial
In order to assess the effect of evolocumab-assisted LDL-C lowering on MACE in persons at high cardiovascular risk who have never experienced a heart attack or stroke, VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, international clinical trial.
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About Repatha® (evolocumab)
A human monoclonal antibody called Repatha functions by preventing the proprotein convertase subtilisin/kexin type 9 (PCSK9) from functioning. By blocking PCSK9, Repatha lowers LDL-C levels by increasing the amount of LDL receptors that can remove LDL (“bad”) cholesterol from the blood. It is authorized in many nations, including the US, to treat excessive cholesterol and lower the risk of cardiovascular events in persons who already have cardiovascular disease.
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