Adverse Events – BiotechReality – Information Intelligence System for Biopharma

Amgen's cholesterol-lowering medication Repatha® (evolocumab) dramatically reduces the risk of a first major adverse cardiovascular event (MACE) in high-risk patients by 25%, according to groundbreaking results from the Phase 3 VESALIUS-CV trial. Over 12,000 high-risk adults with diabetes or atherosclerosis who had never experienced a heart attack or stroke participated in the historic trial, which represents a significant breakthrough in preventative cardiology. The results were concurrently published in the New England Journal of Medicine and presented at the 2025 American Heart Association Scientific Sessions. Repatha showed a strong protective effect when used with common therapies like statins. When comparing the Repatha group to the placebo group, the primary endpoint, a composite of coronary heart disease mortality, heart attack, or ischaemic stroke, was lowered by 25%. Read More: Amgen’s Repatha® (evolocumab) Succeeds in Landmark Phase 3 Trial, Showing Significant Reduction in Cardiovascular Events Key findings from the VESALIUS-CV trial include 25% Reduction in First MACE: A notable drop in the chance of dying from coronary heart disease, having a first heart attack, or having a stroke. 36% Decrease in Heart Attack Risk: The study also revealed a striking 36% decrease in the risk of a heart attack on its own. Broad Cardiovascular Protection: There was a 19% decrease in a broader composite measure of cardiovascular events, which included arterial revascularisation. Read More: Amgen Announces Positive Phase 3 Results for Gastric Cancer Drug Bemarituzumab According to these findings, Repatha is the first and only PCSK9 inhibitor to show a noteworthy decrease in cardiovascular events in patients for both primary prevention (those without a prior event) and secondary prevention. The experiment also demonstrated Repatha's significant effect on reducing "bad" cholesterol. The median LDL-C level for patients in the Repatha arm was 45 mg/dL, while that of patients in the placebo arm was 109 mg/dL. 75% of deaths from cardiovascular disease occur in individuals who have never had one before, making it the world's top cause of death. For many at-risk patients, including the roughly 60% of trial participants with diabetes, this study offers fresh hope. During the experiment, no new safety issues were identified, and Repatha's safety profile remained consistent with previous findings. Information: Amgen Last Modified:

Tag: Adverse Events

Amgen’s Repatha Slashes Risk of First Heart Attack and Stroke by 25% in Landmark Trial

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