Amgen has reported groundbreaking results from the large Phase 3 VESALIUS-CV clinical trial, demonstrating for the first time that its cholesterol-lowering drug Repatha (evolocumab) significantly reduces the risk of major cardiovascular events in high-risk adults who have never previously suffered a heart attack or stroke. The trial, enrolling more than 12,000 patients with elevated LDL cholesterol or risk factors such as diabetes, followed participants for a median of 4.5 years. Adding Repatha to standard therapies, including statins, yielded statistically and clinically significant reductions in the combined risk of coronary heart disease death, heart attacks, strokes, and arterial revascularization procedures compared with standard therapy alone.
This “landmark” result, as described by Amgen, positions Repatha as the first and only PCSK9 inhibitor to show efficacy for both primary and secondary prevention, broadening its potential use to millions globally at risk for developing heart disease. Notably, approximately 85% of study participants were already receiving high-intensity LDL-lowering therapies, emphasizing the additional benefit Repatha provides even for patients with well-treated cholesterol levels.
No new safety signals emerged during the trial, aligning with Repatha’s established tolerability. Industry analysts highlight the findings as a major expansion opportunity for the drug, which could increase clinical uptake in the vast market of high-risk adults without diagnosed cardiovascular disease. The full results are set to be presented at the American Heart Association Scientific Sessions in November 2025, with the potential to quickly influence prescribing guidelines and payer access decisions for primary prevention of cardiovascular events.
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