Amgen (NASDAQ:AMGN) disclosed new clinical and health economic data for Repatha (evolocumab) at the American Heart Association Scientific Sessions 2026 on November 9, 2026, covering cost-effectiveness analyses from the VESALIUS-CV trial and long-term cardiovascular outcomes from the FOURIER open-label extension study.

Key Highlights

  • Cost-effectiveness benchmark: An independent VESALIUS-CV health economic analysis found Repatha to be cost-effective at approximately 36% below the ACC/AHA benchmark for high-risk patients without a prior heart attack or stroke.
  • FOURIER long-term follow-up: Over a maximum follow-up of more than 8 years, Repatha was associated with a 29% lower rate of 3-P MACE and a 25% lower risk of cardiovascular death versus an external control drawn from UK health records.
  • CKD subgroup in VESALIUS-CV: Patients with chronic kidney disease and no prior heart attack or stroke had an approximately 90% higher rate of coronary heart disease death, heart attack, or ischemic stroke compared to patients without CKD; Repatha reduced 3-P MACE in this group by 39% over a median follow-up of 4.6 years.
  • All-cause death reduction in CKD patients: In the VESALIUS-CV CKD subgroup, Repatha reduced the risk of all-cause death by 29% over the same median 4.6-year follow-up period.
  • VESALIUS-CV trial scale: The trial enrolled more than 12,000 patients; the median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL), and participants were followed for a median of approximately 4.6 years.
  • Analysis leadership: The independent VESALIUS-CV health economic analysis was led by the Duke Clinical Research Institute in collaboration with the TIMI Study Group at Mass General Brigham and Harvard.

Repatha Data at AHA 2026: Cost-Effectiveness and Long-Term Outcomes

According to the filing, the first independent health economic analysis using detailed individual participant data from the Phase 3 VESALIUS-CV trial compared treatment costs with projected health benefits. The analysis determined Repatha to be cost-effective at approximately 36% below the ACC/AHA benchmark, applying to high-risk patients without a prior myocardial infarction or stroke. A separate analysis also found adding Repatha to standard therapy to be highly cost-effective versus standard therapy alone in adults living with atherosclerotic cardiovascular disease (ASCVD), according to the disclosure.

The filing also highlighted a pre-specified VESALIUS-CV subgroup analysis in patients with chronic kidney disease (CKD). The company disclosed that patients with CKD and no prior heart attack or stroke faced an approximately 90% higher rate of 3-P MACE compared to patients without CKD. Over a median follow-up of 4.6 years, Repatha was reported to lower 3-P MACE rates by 39%, reduce 4-P MACE by 23%, and lower the risk of all-cause death by 29% in this population. The filing noted that the 2026 AHA/ACC/ADA/ASN Cardiovascular-Kidney-Metabolic Syndrome Guideline recognizes the elevated cardiovascular risk associated with CKD.

Regarding the FOURIER open-label extension (OLE), the company disclosed a new analysis comparing patients treated with Repatha in FOURIER and its OLE against a non-randomized external control from UK health records. Over a maximum follow-up of more than 8 years, the filing states Repatha was associated with a 29% lower rate of 3-P MACE and a 25% lower risk of cardiovascular death. The FOURIER-OLE enrolled over 6,600 patients, with some receiving Repatha for up to 8.4 years in aggregate across both studies, and more than 85% of patients achieved an LDL-C level below 40 mg/dL during the OLE period, according to the filing.

What Was Disclosed

Amgen released new health economic and clinical analyses for Repatha at the AHA Scientific Sessions 2026, covering cost-effectiveness from VESALIUS-CV, cardiovascular outcomes in a CKD subgroup, and long-term MACE and mortality data from the FOURIER OLE external-control analysis.