INDICATIONS

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events... READ MORE

For US healthcare professionals

For your adult patients at increased risk of major adverse cardiovascular events (MACE)

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See full details of the landmark VESALIUS-CV trial at VESALIUS.org

  • PATIENTS WITH
    KNOWN ASCVD

  • PATIENTS AT HIGH CV RISK
    WITHOUT MI OR STROKE

In the FOURIER Trial

Repatha® Plus a Statin Reduced the Risk of CV Events1,2

Repatha® + statin was proven to reduce the risk of composite CV events by 20% in a median of only 2.2 years, and the benefit improved over time in the study1,2

Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke1,2

Time to First Occurrence of CV Death, MI, or Stroke With Repatha® (evolocumab) Placebo plus a statin Graph
  • Primary composite endpoint of time to first occurrence of CV death, Ml, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.85 (95% Cl, 0.79-0.92; P>0.0001)1
  • Relative risk reductions for the primary and secondary composite endpoints were driven by a reduction in the risk of Ml: HR 0.73 (95% Cl, 0.65-0.82), stroke: HR 0.79 (95% Cl, 0.66-0.95), and coronary revascularization: HR 0.78 (95% Cl, 0.71-0.86)1,*

    *Not statistically significant.

  • Observed HR for CV death: 1.05 (95% Cl, 0.88-1.25) and hospitalizations due to unstable angina: 0.99 (95% Cl, 0.82-1.18)1
SAFETY RESULTS

FOURIER CV Outcomes Trial: A double-blind, randomized, placebo-controlled, event-driven trial of 27,564 patients with established CVD and LDL-C ≥70 mg/dL and/or non–HDL-C ≥100 mg/dL, despite high- or moderate-intensity statin therapy. Patients received either subcutaneous injections of Repatha® (evolocumab 140 mg every 2 weeks or 420 mg once monthly) or placebo. The median baseline LDL-C was 92 mg/dL.1,2

SAFETY RESULTS

CI = confidence interval; CV = cardiovascular; HDL-C = high-density lipoprotein cholesterol; HR = hazard ratio; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; P = P value; RRR = relative risk reduction.

Meaningful Reduction of CV Risk Across FOURIER Subgroups

  • RECENT MI

    In a subanalysis of the FOURIER Trial, Repatha® + statin lowered the risk of composite CV events in patients with a recent MI (<12 months)3,4

    RECENT MI Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke3,4
    Time to First Occurrence of CV Death, MI, or Stroke Following a Recent MI With Repatha® (evolocumab) Plus a Statin vs Placebo Graph
    • Recent MI patients within 1 year of a heart attack have a higher CV risk3,5
    • ARR of 2.0% in the overall FOURIER CV Outcomes Trial study population was demonstrated at 36 months2
    • Observed HR for CV death in the primary analysis 1.05 (95% CI, 0.88-1.25)1

    ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction.

  • PCI

    In a post-hoc analysis of the FOURIER Trial, Repatha® + statin lowered the risk of composite CV events in patients with prior PCI6,7

    Major CV events were the composite of coronary death, MI, or coronary revascularization6,7
    Time to Major CV Event Following a Prior PCI With Repatha® (evolocumab) Placebo plus a statin Graph
    • Analysis of 17,073 patients with a prior PCI in the FOURIER CV Outcomes Trial6,7
    • ARR of 2.0% in the overall FOURIER CV Outcomes Trial study population was demonstrated at 36 months2
    • Observed HR for CV death in the primary analysis: 1.05 (95% CI, 0.88-1.25)1
    • Post-hoc analyses are exploratory and no statistical conclusions can be drawn

    ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction; PCI = percutaneous coronary intervention; RRR = relative risk reduction.

  • DIABETES

    In a post-hoc analysis of the FOURIER Trial, Repatha® + statin lowered the risk of composite CV events in patients with diabetes8,9

    Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke8,9
    meaningful-reduction-diabetes-mvb 1
    • Analysis of 11,031 patients with diabetes in the FOURIER CV Outcomes Trial1
    • For patients with diabetes: Primary composite efficacy endpoint of time to first occurrence of CV death, MI, hospitalization for unstable angina, stroke, or coronary revascularization: HR 0.83 (95% CI, 0.75-0.93); ARR: 2.7%9
    • ARR of 2.0% in the overall FOURIER CV Outcomes Trial study population was demonstrated at 36 months2
    • The observed HR for CV death was 1.05 (95% CI, 0.88-1.25) and for hospitalization due to unstable angina was 0.99 (95% CI, 0.82-1.18) from the primary analysis
    • Post-hoc analyses are exploratory and no statistical conclusions can be drawn

    ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction; RRR = relative risk reduction.

  • PAD

    In a post-hoc analysis of the FOURIER Trial, Repatha® + statin lowered the risk of composite CV events in patients with symptomatic PAD10

    Key secondary endpoint: composite of time to first occurrence of CV death, MI, or stroke10
    meaningful-reduction-PAD
    • 13% (n=3,642) of patients in the FOURIER CV Outcomes Trial were identified as having symptomatic PAD at baseline if they had intermittent claudication and an ankle-brachial index (ABI) of <0.85, or a prior peripheral vascular procedure10
    • Observed HR for CV death in primary analysis was 1.05 (95% CI, 0.88-1.25)1
    • ARR of 2.0% in the overall FOURIER CV Outcomes Trial study population was demonstrated at 36 months2
    • Post-hoc analyses are exploratory and no statistical conclusions can be drawn

    ARR = absolute risk reduction; CI = confidence interval; CV = cardiovascular; HR = hazard ratio; MI = myocardial infarction; PAD = peripheral artery disease; RRR = relative risk reduction.

Achieve ACC Consensus Pathway Recommended Levels of LDL-C <55 mg/dL With Repatha® 1,2,11,*,†

Adding Repatha® resulted in sustained and consistent LDL-C reduction2,12

concensus-pathway-levels
84% of patients
taking Repatha® + statin achieved LDL-C <55 mg/dL at 4 weeks11

ASCVD = atherosclerotic cardiovascular disease; CI = confidence interval; LDL-C = low-density lipoprotein cholesterol.

*Threshold for very high-risk ASCVD patients.

†The 2022 ACC Expert Consensus Decision Pathway (referred herein as ACC Consensus Pathway) was designed to address current gaps in care for LDL-C lowering to reducing ASCVD risk. This effort relies extensively on the evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multisociety cholesterol guidelines, and provides further recommendations regarding the use of newer nonstatin therapies. It should be noted that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance for situations not covered by the previously published guidelines until the next round of formal review of scientific evidence.13

  • ARE STATINS OR EZETIMIBE ENOUGH?14

    In a descriptive, retrospective analysis of 186,670 ASCVD patients with index LDL-C >70 mg/dL (mean index LDL-C of 108 mg/dL):

    Only

    21% of ASCVD patients

    who intensified statins achieved LDL-C values ≤70 mg/dL14,*

    Only

    23% of ASCVD patients

    who added ezetimibe to statin therapy achieved LDL-C values ≤70 mg/dL14,*

    Patients were identified between January 1, 2012 and August 31, 2014, using the IQVIA US ambulatory electronic medical record database. Treatment exposure to statin and/or ezetimibe was based on observation of a valid prescription record in the EMR database, which does not guarantee that the patient filled the prescription or used the medication. This was a descriptive, retrospective analysis that evaluated the associations between exposures and outcomes but no causal relationships can be established from this observation study.14

    *Baseline statin intensity: Among the 75,523 patients with ASCVD treated at baseline, 12.18% were on low statin intensity, 58.4% were on moderate statin intensity, 20.6% were on high-statin intensity, and 8.8% were treated with other lipid-lowering agents.14

    ASCVD = atherosclerotic cardiovascular disease; EMR = electronic medical record; IQVIA = IMS Quintiles Virtual Information Access; LDL-C = low-density lipoprotein cholesterol.

  • SAFETY RESULTS

    Add Repatha®: a proven safety profile12

    In the FOURIER Trial Repatha® had a demonstrated safety profile in over 27,000 patients in a median of 2.2 years1,2

      Repatha® + statin N=13,784 Median achieved LDL-C† 26 mg/dL1 Statin + placebo N=13,780 Median achieved LDL-C† 89 mg/dL1
    Number of patients n=13,769 n=13,756
    Adverse events (% of patients)
    Diabetes 8.8 8.2
    Adjudicated case of new-onset diabetes 8.1 7.7
    Nasopharyngitis 7.8 7.4
    Upper respiratory tract infection 5.1 4.8
    Muscle-related event 5.0 4.8
    Allergic reaction 3.1 2.9
    Injection-site reaction 2.1 1.6
    Cataract 1.7 1.8
    Neurocognitive event 1.6 1.5
    Rhabdomyolysis 0.1 0.1

    Hemorrhagic stroke: 0.21% statin + Repatha® (n=13,784), 0.18% statin + placebo (n=13,780).‡

    †Median LDL-C achieved at 48 weeks.

    ‡The total number of patients were 8,337 in the Repatha® + statin group and 8,339 in the placebo + statin group because patients with prevalent diabetes at the start of the trial were excluded.

    Long-term safety data from FOURIER-OLE was consistent with the established safety profile in FOURIER2,12

    8.4 Years Icon8.4-years-icon

    FOURIER-OLE is the longest trial of PCSK9i mAb to date, with some Repatha® patients followed continuously for up to 8.4 years across FOURIER and FOURIER-OLE16

    Heart IconHeart Icon

    No new safety signals were detected, and the incidence of serious AEs did not increase over time. The incidence of serious AEs was similar in patients achieving very low LDL-C levels (<20 mg/dL) and those with higher LDL-C12,16

    0.1% Icon0.1% Icon

    Discontinuation rate due to AEs attributed to Repatha® during FOURIER-OLE was 0.1%12,§

    FOURIER Open-Label Extension Study (FOURIER-OLE): Open-label extension of FOURIER trial. Analyses were pooled across the two OLE studies. 6,635 patients received Repatha® 140 mg every 2 weeks or 420 mg once a month (3,355 randomized to Repatha®, 3,280 to placebo in the parent trial). Median time on therapy was 7.1 years for those originally randomized to Repatha® (evolocumab) and 5 years for those originally randomized to placebo in the parent trial. The primary endpoint was the subject incidence of treatment-emergent events.

    AEs = adverse events; CV = cardiovascular; LDL-C = low-density lipoprotein cholesterol; mAb = monoclonal antibody; OLE = open-label extension; PCSK9i = proprotein convertase subtilisin/kexin type 9 inhibitor.

    §Consider open-label extension study limitations when interpreting the results. The open-label extension study is not blinded, not controlled, and includes inherent self-selection bias.

Brain Cognitive Function IconBrain Cognitive Function Icon

Lowering LDL-C With Repatha® Did Not Impair Cognitive Function1

EBBINGHAUS studied 1,974 patients from the FOURIER CV Outcomes Trial1

  • Patients were assessed using neuropsychological function tests over a median follow-up of 19 months1
  • Study concluded noninferiority in select cognitive function domains was observed between Repatha® (evolocumab) and placebo when added to statin1
  • 661 patients achieved LDL-C <25 mg/dL with Repatha®17

In the VESALIUS-CV Trial

REPATHA® Significantly Reduced the Risk of Composite MACE in Patients at High CV Risk Without Prior MI or Stroke1,2

VESALIUS-CV Trial: A phase 3 randomized, double-blind, placebo-controlled, global trial evaluating the impact of evolocumab on major cardiovascular events in patients at high CV risk without prior MI or stroke (N=12,301). Includes patients with significant CAD without MI, significant atherosclerotic cerebrovascular disease without stroke, significant PAD, and/or high-risk diabetes (defined as diabetes that is long-standing [≥10 years], complicated by microvascular disease, or daily insulin use). All patients had at least 1 additional high-risk criterion (examples include age ≥65 years; current tobacco use; and LDL-C ≥130 mg/dL, or non-HDL-C ≥160 mg/dL or ApoB ≥120 mg/dL). Patients received either subcutaneous injections of Repatha® (140 mg) or matching placebo every 2 weeks in addition to stable, optimized LLT. At baseline, median LDL-C was 122 mg/dL.3

ARR = absolute risk reduction; CAD = coronary artery disease; CHD = coronary heart disease; CI = confidence interval; CV = cardiovascular; HDL-C = high-density lipoprotein cholesterol; CVD = cardiovascular disease; HR = hazard ratio; LDL-C = low-density lipoprotein cholesterol; LLT = lipid-lowering therapy; MACE = major adverse cardiac events; MI = myocardial infarction; P = P value; PAD = peripheral artery disease; RRR = relative risk reduction.

*CHD death was not statistically significant; therefore, subsequent secondary endpoints, including ischemic stroke, were not formally tested and should be interpreted as exploratory.

More is needed to help achieve recommended LDL-C levels

*According to VESALIUS-REAL, a real-world global retrospective observational study that evaluated the effect of evolocumab in patients at high CV risk without prior MI or stroke. ~280,000 were US patients and had a history of CAD, PAD, CeVD, or high-risk diabetes. Median baseline LDL-C was 119 mg/dL. 60% of these patients were not receiving LLT at index (earliest date when patients met all eligibility criteria). Within 1 year of follow-up, 49.9% of patients had ≥1 LDL-C result (n=178,361).4

Dramatically lower LDL-C with Repatha®2

In a substudy of ~2000 patients from the VESALIUS-CV Trial, Repatha® + standard lipid-lowering treatment* substantially lowered LDL-C compared with standard lipid-lowering treatment* alone2

LDL-C = low-density lipoprotein cholesterol; LLT = lipid-lowering therapy.

*Standard lipid-lowering treatment defined as maximally tolerated statin plus or minus ezetimibe.3

†In the overall study population, the median baseline LDL-C level was 122 mg/dL. 87% of patients were taking a statin and 73% were on high-intensity therapy. High-intensity lipid-lowering regimen was defined as daily treatment with either a high-intensity statin (eg, atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily) or a combination of a statin at any approved daily dose and ezetimibe.2

‡The substudy was designed to measure LDL-C at the 48-week visit.2

This subgroup analysis is exploratory and no statistical conclusion can be drawn.

Add Repatha®—an established safety profile2,3

  • In VESALIUS-CV, treatment-emergent serious AEs were followed over a median of ~4.5 years in 12,301 patients (randomized to Repatha® or placebo)1,3
  • Incidence of serious adverse events did not increase over time2
  • Incidence of serious adverse events was similar in patients with very low LDL-C levels (<20 mg/dL mg/dL) and those with higher LDL-C levels2
  • Discontinuation rate with Repatha® was [X.X%]2

CV = cardiovascular.
Analysis conducted in the safety population, which includes all patients who underwent randomization and received at least one dose of Repatha®. Counts are shown for the number of patients with relevant events and the proportion is the number of patients with a relevant event divided by the total number of patients in the safety population.2

  • Study Design

    In the VESALIUS-CV Outcomes Trial, Repatha® was evaluated in patients at high CV risk with high-risk diabetes or ASCVD without a prior MI or stroke3

    AEs = adverse events; ApoB = apolipoprotein B; CAD = coronary artery disease; CeVD = cerebrovascular disease; CHD = coronary heart disease; CV = cardiovascular; DM = diabetes mellitus; HDL-C = high-density lipoprotein cholesterol; IDR = ischemia-driven arterial revascularization; LDL-C = low-density lipoprotein cholesterol; LLT = lipid-lowering therapy; MACE = major adverse cardiovascular events; MI = myocardial infarction; PAD = peripheral artery disease; Q2W = twice weekly; SC = subcutaneous.

    *IDR is defined as revascularization of any vascular bed, including coronary, cerebrovascular, or peripheral, performed in the presence of ischemia of the relevant end-organ.3

    †High-intensity lipid-lowering regimen was defined as daily treatment with either a high-intensity statin (eg, atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily) or a combination of a statin at any approved daily dose and ezetimibe.3

References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Sabatine MS, Giugliano RP, Keech AC, et al; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 3. Gencer B, Mach F, Murphy SA, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5:952-957. 4. Gencer B, Mach F, Murphy SA, et al. Efficacy of evolocumab on cardiovascular outcomes in patients with recent myocardial infarction: a prespecified secondary analysis from the FOURIER trial. JAMA Cardiol. 2020;5:952-957. Supplementary Online Content. doi:10.1001/jamacardio.2020.0882 5. Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015;36:1163-1170. 6. Furtado RHM, Fagundes AA, Oyama K, et al. Effects of evolocumab in patients with prior percutaneous coronary intervention: an analysis from the FOURIER trial. Presented at: American Heart Association Scientific Sessions 2020; November 13-17, 2020. 7. Furtado RHM, Fagundes AA Jr, Oyama K, et al. Effect of evolocumab in patients with prior percutaneous coronary intervention. Circ Cardiovasc lnterv. 2022;15:e011382. 8. Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular efficacy & safety of evolocumab in diabetes, and risk of development of diabetes: an analysis from the FOURIER trial. Presented at: 53rd Annual Meeting of the European Association for the Study of Diabetes; Lisbon, Portugal; September 15, 2017. 9. Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5(12):941-950. doi:10.1016/S2213-8587(17)30313-3 10. Bonaca MP, Nault P, Giugliano RP, et al. Low-density lipoprotein cholesterol lowering with evolocumab and outcomes in patients with peripheral artery disease: insights from the FOURIER Trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018;137:338-350. 11. Data on file, Amgen; 2022. 12. O’Donoghue ML, Giugliano RP, Wiviott SD, et al. Long-term evolocumab in patients with established atherosclerotic cardiovascular disease. Circulation. 2022;146:1109-1119. 13. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80:1366-1418. 14. Chen C-C, Rane PB, Hines DM, Patel J, Harrison DJ, Wade RL. Low-density lipoprotein cholesterol outcomes post-non-PCSK9i lipid-lowering therapies in atherosclerotic cardiovascular disease and probable heterozygous familial hypercholesterolemia patients. Ther Clin Risk Manag. 2018;14:2425-2435. 15. Data on file, Amgen; 2025. 16. Gaba P, O’Donoghue ML, Park J-G, et al. Association between achieved low-density lipoprotein cholesterol levels and long-term cardiovascular and safety outcomes: an analysis of FOURIER-OLE. Circulation. 2023;147:1192-1203. 17. Giugliano RP, Mach F, Zavitz K, et al. Cognitive function in a randomized trial of evolocumab. N Engl J Med. 2017;377:633-643.

References: 1. Amgen. New Release; October 2025. 2. Bohula E, et al. Oral presentation presented at: American Heart Association; November 7-10, 2025; New Orleans, LA. 3. Bohula EA, Marston NA, Ruzza A, et al. Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial. Am Heart J. 2024:269:179-190. 4. Chan Q, Sakhuja S, Ochs A, et al. Lipid-lowering therapy use in high-risk ASCVD patients without prior MI or stroke—preliminary data from VESALIUS-REAL, US. Poster presented at: American College of Cardiology Annual Meeting; March 29–31, 2025; Chicago, IL, USA.

Important Safety Information

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hypercholesterolemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse Reactions in the FOURIER Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Indications

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and in adults with heterozygous familial hypercholesterolemia (HeFH)

Please see full Prescribing Information.

Important Safety Information

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