THOUSAND OAKS (dpa-AFX) - Amgen Inc. (AMGN) announced new data for Repatha (evolocumab) in high-risk patients, with analyses examining low-density lipoprotein cholesterol (LDL-C) lowering, cardiovascular outcomes and cost-effectiveness. The company presented the data at the American Heart Association (AHA) Scientific Sessions 2026.
The first independent health economic analysis used detailed data from individual participants in the Phase 3 VESALIUS-CV trial to compare treatment costs with projected health benefits.
VESALIUS-CV is a Phase 3, double-blind, randomised, placebo-controlled, global clinical trial designed to evaluate whether LDL-C lowering with evolocumab reduces major adverse cardiovascular events (MACE) in adults at high cardiovascular risk without a prior heart attack or stroke.
According to the company, the analysis found Repatha cost-effective, with an estimated cost about 36% below the ACC/AHA cost-effectiveness benchmark.
Furthermore, a separate analysis found adding Repatha to standard therapy to be highly cost-effective versus standard therapy alone in adults living with atherosclerotic cardiovascular disease (ASCVD).
Results included analyses building on VESALIUS-CV and FOURIER studies, highlighting Repatha's CV benefit in primary prevention patients with chronic kidney disease (CKD) and long-term follow-up in patients with ASCVD.
A pre-specified analysis of the VESALIUS-CV trial found that patients with chronic kidney disease (CKD) and no prior heart attack or stroke face a significantly higher cardiovascular risk, with an approximately 90% greater rate of coronary heart disease death, myocardial infarction, or ischemic stroke (three-point major adverse cardiovascular events, or 3-point MACE) than those without CKD.
Over a median follow-up of 4.6 years, Repatha significantly reduced cardiovascular risk in patients with CKD, lowering the rate of 3-point major adverse cardiovascular events (MACE) by 39%, 4-point MACE by 23%, and all-cause mortality by 29%.
In addition, a new analysis also evaluated Repatha's long-term effectiveness by comparing patients treated with Repatha in FOURIER and its open-label extension (OLE) with a non-randomised external control drawn from UK health records.
The analysis showed that, over a maximum follow-up of more than 8 years, Repatha was associated with a 29% lower rate of 3-P MACE, a composite of heart attack, stroke or CV death, and a 25% lower risk of CV death, suggesting that Repatha's CV benefits may be sustained beyond the randomised trial period.
According to company estimates, a heart attack occurs every 40 seconds in the United States, and roughly 75% of these events are first-time heart attacks, underscoring the need for preventive cardiovascular care.
AMGN has traded between $312.39 and $483.99 over the past 52 weeks. The stock closed Monday's trade at $465.23, up 1.04%.
In the after-hours market, AMGN is up 0.16% at $465.96.
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