MedPath

Evolocumab

Generic Name
Evolocumab
Brand Names
Repatha
Drug Type
Biotech
CAS Number
1256937-27-5
Unique Ingredient Identifier
LKC0U3A8NJ

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.
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