THOUSAND OAKS, Calif. – November 10, 2026 -- Amgen reported that an independent health economic analysis of its PCSK9 inhibitor Repatha (evolocumab) found the drug cost-effective at approximately 36% below the ACC/AHA benchmark in high-risk patients with no prior heart attack or stroke. The company presented the data at the American Heart Association (AHA) Scientific Sessions 2026.
Duke-led analysis uses patient-level VESALIUS-CV data
The Duke Clinical Research Institute led the study with the TIMI Study Group at Mass General Brigham and Harvard. It is the first independent health economic analysis built on individual-participant data from the Phase 3 VESALIUS-CV trial, and it compared treatment costs with projected health benefits. A separate analysis found that adding Repatha to standard therapy was highly cost-effective versus standard therapy alone in adults with atherosclerotic cardiovascular disease (ASCVD).
Murdo Gordon, Amgen's executive vice president of Global Markets and Policy, said the company has taken steps to make Repatha more affordable and accessible. He tied the data to the guideline LDL-C goal below 55 mg/dL for high-risk patients.
Repatha cuts major cardiovascular events by 39% in patients with chronic kidney disease
A pre-specified VESALIUS-CV analysis found that patients with chronic kidney disease (CKD) and no prior heart attack or stroke had an approximately 90% higher rate of coronary heart disease death, heart attack or ischemic stroke (3-P MACE) than patients without CKD. Over a median follow-up of 4.6 years, Repatha lowered 3-P MACE rates by 39% in the CKD group. It reduced 4-P MACE, which adds ischemia-driven arterial revascularization, by 23%, and cut the risk of all-cause death by 29%.
The 2026 AHA/ACC/ADA/ASN Cardiovascular-Kidney-Metabolic Syndrome Guideline recognizes the elevated cardiovascular risk tied to CKD. It emphasizes managing comorbid risk factors, including high LDL-C.
FOURIER external-control analysis shows 29% lower 3-P MACE over more than eight years
Amgen compared patients treated with Repatha in FOURIER and its open-label extension (OLE) with a non-randomized external control drawn from UK health records. Over a maximum follow-up of more than 8 years, Repatha was associated with a 29% lower rate of 3-P MACE (heart attack, stroke or cardiovascular death) and a 25% lower risk of cardiovascular death. Amgen said the result adds evidence that the benefits persist beyond the randomized trial period.
Underlying trials set the efficacy baseline
VESALIUS-CV enrolled more than 12,000 patients without prior heart attack or stroke and followed them for a median of about 4.6 years. Results published in the New England Journal of Medicine in November 2025 showed a 25% relative reduction in 3-P MACE, a 19% reduction in 4-P MACE and a 36% reduction in heart attack risk. Median LDL-C was 45 mg/dL on Repatha versus 109 mg/dL on placebo in a lipid sub-study.
FOURIER enrolled more than 27,000 patients with established ASCVD. Repatha lowered LDL-C by 59%, from a median 92 mg/dL to 30 mg/dL, and reduced the composite of cardiovascular death, myocardial infarction or stroke by 20%. The FOURIER-OLE study enrolled over 6,600 patients in Europe and the United States, with some receiving Repatha for up to 8.4 years in aggregate. More than 85% reached LDL-C below 40 mg/dL during the OLE period, and no new long-term safety findings were observed.
Amgen presented ten abstracts in total at the meeting. They cover LDL-C testing after hospitalization, clinician education, a digital health-enabled lipid program, lipoprotein(a) prevalence, and persistence and adherence among patients starting GLP-1-based therapies.