Overview
Evolocumab is a monoclonal antibody designed for the treatment of hyperlipidemia by Amgen. It is a subcutaneous injection approved by the FDA for individuals on maximum statin therapy who still require additional LDL-cholesterol lowering. It is approved for both homozygous and heterozygous familial cholesterolemia as an adjunct to other first-line therapies. Evolocumab is a human IgG2 monoclonal antibody that targets the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation, therefore reducing the liver's ability to remove LDL-cholesterol (LDL-C), or "bad" cholesterol, from the blood. Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface, resulting in more LDL receptors on the surface of the liver to remove LDL-C from the blood. Evolocumab is the second PCSK9 inhibitor on the market, first being alirocumab.
Indication
Evolocumab is indicated in adult patients with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization. It is also indicated as an adjunct to diet, alone or in combination with other hypolipidemic treatments, in adults with primary hyperlipidemia (and in pediatric patients ≥10 years old with heterozygous familial hypercholesterolemia) to reduce LDL-C. In addition, it is indicated adjunctly to other hypolipidemic treatments in patients ≥10 years old with homozygous familiar hypercholesterolemia to reduce LDL-C.
Associated Conditions
- Coronary Revascularization
- Myocardial Infarction
- Stroke
- Increases in serum total low-density lipoprotein (LDL)
Research Report
Evolocumab (Repatha®): A Comprehensive Monograph on a PCSK9 Inhibitor for Cardiovascular Risk Reduction
Executive Summary
Evolocumab represents a significant advancement in lipid-lowering therapy, embodying the successful translation of genetic discovery into a targeted biologic agent for cardiovascular risk reduction. As a fully human immunoglobulin G2 (IgG2) monoclonal antibody, evolocumab functions by selectively inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9), a key regulator of low-density lipoprotein receptor (LDLR) metabolism. By preventing PCSK9-mediated degradation of LDLRs, evolocumab enhances the liver's capacity to clear low-density lipoprotein cholesterol (LDL-C) from circulation, resulting in profound and sustained reductions in plasma LDL-C levels.
The clinical development of evolocumab, under the comprehensive PROFICIO program, has furnished a robust body of evidence supporting its efficacy and safety across a wide spectrum of patient populations. The landmark cardiovascular outcomes trial, FOURIER, demonstrated that the addition of evolocumab to statin therapy in patients with established atherosclerotic cardiovascular disease (ASCVD) significantly reduces the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and coronary revascularization. This benefit was shown to accrue over time, a finding reinforced by long-term open-label extension studies. Furthermore, pivotal trials have established its efficacy in patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH), including pediatric populations, as well as in patients with statin intolerance.
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/09 | N/A | Completed | |||
2023/08/04 | Phase 4 | Not yet recruiting | Xiang Xie | ||
2023/08/03 | N/A | Completed | |||
2023/04/06 | Phase 4 | Recruiting | Zibo Central Hospital | ||
2023/02/23 | Phase 3 | Recruiting | |||
2023/01/25 | Phase 4 | Not yet recruiting | Second Affiliated Hospital of Guangxi Medical University | ||
2022/12/22 | Phase 4 | Completed | |||
2022/12/08 | Phase 4 | Recruiting | |||
2022/11/14 | Phase 4 | Recruiting | Henan Institute of Cardiovascular Epidemiology | ||
2022/10/18 | Phase 4 | Recruiting | Wuhan Union Hospital, China |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.