THOUSAND OAKS, Calif. -- September 01, 2026 -- Amgen said its cholesterol drug Repatha reduced the risk of death by 20% among more than 12,000 high-risk adults who had not yet suffered a heart attack or stroke, based on a pre-specified analysis of the Phase 3 VESALIUS-CV trial. The company presented the data in a late-breaking session at the European Society of Cardiology Congress 2026 in Munich, Germany, and published the findings simultaneously in Circulation. Amgen said the result marks the first time a PCSK9 inhibitor has shown a reduction in all-cause mortality among primary prevention patients in a Phase 3 study.
Repatha Cuts Overall and Cardiovascular Deaths Over 4.6 Years of Follow-Up
The mortality benefit began to appear after roughly 1.5 years of treatment and continued through a median follow-up of 4.6 years, Amgen reported. Evolocumab, sold as Repatha, reduced both overall deaths and cardiovascular deaths among trial participants, who had atherosclerotic cardiovascular disease or high-risk diabetes but no prior heart attack or stroke. Median baseline LDL-C among enrolled patients was 122 mg/dL, and a lipid sub-study found Repatha lowered median LDL-C to 45 mg/dL versus 109 mg/dL for placebo.
Heart Attack Risk Fell Within Six Months of Starting Treatment
Two additional VESALIUS-CV analyses found Repatha reduced first, subsequent and total cardiovascular events, with lower heart attack risk emerging as early as six months after treatment began. Amgen said the reduction was driven mainly by fewer heart attacks caused by plaque rupture and fewer larger infarctions. The company reported the benefits held consistent across key patient subgroups.
Jay Bradner, Amgen's executive vice president of Research and Development, Artificial Intelligence and Data, said the totality of the data "is practice-changing." Earlier results from VESALIUS-CV, published in the New England Journal of Medicine in November 2025, showed Repatha cut the risk of a composite of coronary heart disease death, heart attack or ischemic stroke by 25%, reduced a broader four-point composite by 19%, and lowered heart attack risk by 36%.
Real-World Studies Find Women and High-Risk Patients Remain Undertreated
Separate global real-world analyses presented at the congress found many high-risk patients with coronary artery disease but no prior heart attack or stroke failed to reach recommended LDL-C targets, reflecting low rates of treatment initiation, intensification and monitoring. A second study found women at high risk without a prior heart attack or stroke were less likely than men to receive intensive lipid-lowering treatment or achieve LDL-C goals across the regions studied.
Regulators in the US and EU Have Expanded Repatha's Approved Use
The U.S. FDA broadened Repatha's approved use in August 2025 to cover adults at increased risk for major cardiovascular events due to uncontrolled LDL-C. The European Commission followed in August 2026, approving an expanded indication based on the VESALIUS-CV results for adults with established or high risk for atherosclerotic cardiovascular disease. Repatha is now approved in 75 countries, including the U.S., Japan, Canada and all 28 EU member states, and has been used by approximately 9 million patients globally since its first approval in 2015.