• 10 Nov 2025
• Admin
• News Article

Amgen’s Repatha® (Evolocumab) Significantly Reduces Cardiovascular Events in High-Risk Patients Without Prior Heart Attack or Stroke — Phase 3 VESALIUS-CV Results Announced

Amgen (NASDAQ: AMGN) announced full results from its Phase 3 VESALIUS-CV trial, demonstrating that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in adults at high cardiovascular risk without a prior heart attack or stroke, when added to standard lipid-lowering therapy.

Presented at the American Heart Association (AHA) 2025 Scientific Sessions and published simultaneously in the New England Journal of Medicine, these findings establish Repatha as the first and only PCSK9 inhibitor proven to reduce cardiovascular events in both primary and secondary prevention settings.

Key Outcomes

• Population: >12,000 adults with atherosclerosis or diabetes, no prior heart attack or stroke.
• Primary Results:
  - 25% relative reduction in the composite of CHD death, heart attack, or ischemic stroke (3-point MACE).
  - 19% reduction in an expanded composite including ischemia-driven revascularization (4-point MACE).
  - 36% reduction in heart attack risk.
• Lipid Outcomes: Median achieved LDL-C of 45 mg/dL vs 109 mg/dL in placebo group.
• Diabetes Subgroup: Nearly 60% of participants had diabetes; results confirmed consistent risk reduction.
• Safety: No new safety concerns identified; tolerability consistent with prior studies and labeling.

Expert Insights

“The VESALIUS-CV results deliver compelling evidence that intensive LDL-C lowering prevents cardiovascular events—even before one occurs,” said Dr. Jay Bradner, EVP of R&D at Amgen.

“In patients without a history of heart attack or stroke, adding evolocumab substantially reduced MACE risk,” added Dr. Marc S. Sabatine, Chair of the TIMI Study Group, Brigham and Women’s Hospital.

Clinical Context

Cardiovascular disease (CVD) remains the leading global cause of death. Approximately 75% of heart attacks and strokes are first-time events, and high LDL-C is one of the most modifiable risk factors.

Building on its FOURIER study results, which showed reduced recurrent events in secondary prevention, Amgen’s VESALIUS-CV trial broadens Repatha’s demonstrated benefit to high-risk primary prevention populations.

About the VESALIUS-CV Trial

A Phase 3, double-blind, randomized, placebo-controlled study evaluating evolocumab’s effect on MACE in high-risk adults without prior MI or stroke. Participants had ASCVD or high-risk diabetes with LDL-C ≥90 mg/dL despite optimal therapy. Median follow-up: 4.6 years.

About Repatha® (Evolocumab)

Repatha is a human monoclonal antibody that inhibits PCSK9, increasing LDL receptor availability and lowering LDL-C. It is approved in 74 countries for reducing cardiovascular risk and managing hypercholesterolemia, with 57,000+ patients studied in 51 clinical trials.

Amgen’s Cardiovascular Commitment

Amgen continues to expand its cardiovascular pipeline, targeting key disease drivers such as LDL-C, Lp(a), obesity, diabetes, and hypertension, combining innovation with access programs like AmgenNow, which offers Repatha in the U.S. at $239/month.