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.
Background
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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/05 | N/A | Recruiting | |||
2024/12/18 | N/A | Active, not recruiting | Shanghai Zhongshan Hospital | ||
2024/11/22 | Phase 2 | Recruiting | |||
2024/04/15 | Not Applicable | Recruiting | Beijing Luhe Hospital | ||
2024/02/29 | Phase 2 | Active, not recruiting | |||
2024/01/30 | Phase 4 | Completed | |||
2023/11/18 | Early Phase 1 | Not yet recruiting | |||
2023/11/18 | N/A | Not yet recruiting | |||
2023/10/13 | Early Phase 1 | Not yet recruiting | |||
2023/10/13 | Phase 3 | Active, not recruiting | Sejong General Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Amgen USA Inc. | 72511-750 | SUBCUTANEOUS | 140 mg in 1 mL | 1/25/2024 | |
Amgen USA Inc. | 72511-393 | SUBCUTANEOUS | 140 mg in 1 mL | 5/20/2025 | |
Amgen Inc | 55513-750 | SUBCUTANEOUS | 140 mg in 1 mL | 6/7/2023 | |
Amgen USA Inc. | 72511-501 | SUBCUTANEOUS | 140 mg in 1 mL | 5/20/2025 | |
Amgen USA Inc. | 72511-760 | SUBCUTANEOUS | 140 mg in 1 mL | 1/25/2024 | |
Amgen Inc | 55513-760 | SUBCUTANEOUS | 140 mg in 1 mL | 6/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/17/2015 | ||
Authorised | 7/17/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
REPATHA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140MG/ML | SIN15223P | INJECTION, SOLUTION | 140 mg/ml | 4/24/2017 | |
REPATHA SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140MG/ML | SIN15224P | INJECTION, SOLUTION | 140mg/ml | 4/24/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Evolocumab Injection | 国药准字SJ20202002 | 生物制品 | 注射剂 | 12/28/2022 | |
Evolocumab Injection | 国药准字SJ20180022 | 生物制品 | 注射剂 | 12/28/2022 | |
Evolocumab Injection | 国药准字SJ20180021 | 生物制品 | 注射剂 | 12/28/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD | 348651 | Medicine | A | 12/3/2020 | |
REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector | 231152 | Medicine | A | 12/9/2015 | |
REPATHA evolocumab (rch) 140 mg/mL injection solution syringe | 231151 | Medicine | A | 12/9/2015 |