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NEW DATA AT AHA 2026 DEMONSTRATES THE VALUE OF TREATMENT WITH REPATHA® EARLIER IN THE CARDIOVASCULAR RISK CONTINUUM

AMGN
  • Amgen announced new data at the American Heart Association (AHA) Scientific Sessions 2026 on November 9, 2026, supporting Repatha (evolocumab) for intensive LDL-C lowering in high-risk patients.
  • An independent VESALIUS-CV health economic analysis found Repatha highly cost-effective for high-risk patients without a prior heart attack or stroke, with costs approximately 36% below the ACC/AHA benchmark.
  • A separate FOURIER external-control analysis showed Repatha associated with a 29% lower risk of major cardiovascular events over a maximum follow-up of more than 8 years compared to standard therapy alone.
  • In patients with chronic kidney disease (CKD) and no prior heart attack or stroke, Repatha reduced 3-P MACE rates by 39%, 4-P MACE by 23%, and all-cause death by 29% over a median follow-up of 4.6 years.
  • The VESALIUS-CV trial demonstrated Repatha reduced the risk of coronary heart disease death, heart attack, or ischemic stroke by 25% and heart attack risk by 36% in adults without prior cardiovascular events.
  • Repatha lowered LDL-C levels to a median of 45 mg/dL in the VESALIUS-CV trial compared to 109 mg/dL in the placebo group when added to statin and/or ezetimibe therapy.
  • Long-term data from the FOURIER open-label extension showed more than 85% of patients achieved LDL-C levels below 40 mg/dL, with no new long-term safety findings observed.
  • The U.S. FDA broadened Repatha's approved use in August 2025 for adults at increased risk for major adverse CV events due to uncontrolled LDL-C, while the European Commission approved an expanded indication in August 2026.
  • Approximately 9 million patients globally have used Repatha since its 2015 approval, with ~96% coverage across U.S. insurance types and most patients paying less than $50/month.
  • Amgen highlighted that Repatha is the only PCSK9 inhibitor to demonstrate significant cardiovascular event reduction in both primary and secondary prevention settings.
  • Adverse reactions reported in adults included nasopharyngitis, upper respiratory tract infections, influenza, back pain, injection site reactions, and a slightly higher incidence of new-onset diabetes mellitus compared to placebo in the FOURIER trial.
  • Repatha is contraindicated in patients with a history of serious hypersensitivity reactions to evolocumab or its excipients, including angioedema.
  • The drug is approved in 75 countries, including the U.S., Japan, Canada, and all 28 European Union member states, with applications pending in other regions.
Company
Amgen
Keywords
Amgen