MedPath

Evolocumab

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

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

Phase 2
Completed
Conditions
Atherosclerotic Cardiovascular Disease
Symptomatic Atherosclerosis
Type2 Diabetes
Familial Hypercholesterolemia
Interventions
First Posted Date
2017-02-23
Last Posted Date
2023-03-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
382
Registration Number
NCT03060577
Locations
🇬🇧

Novartis Investigative Site, Worcester, United Kingdom

Evolocumab Pregnancy Exposure Registry

Terminated
Conditions
Hypercholesterolemia; ASCVD; Pregnancy
Interventions
First Posted Date
2016-11-08
Last Posted Date
2020-12-17
Lead Sponsor
Amgen
Target Recruit Count
140
Registration Number
NCT02957604

Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2016-10-28
Last Posted Date
2021-11-03
Lead Sponsor
Marja-Riitta Taskinen
Target Recruit Count
14
Registration Number
NCT02948777
Locations
🇫🇮

Helsinki University Hospital, Biomedicum 2U, Helsinki, Finland

Vascular Inflammation and Cholesterol Lowering Therapy

Phase 4
Withdrawn
Conditions
Lipid Lowering, Vascular Inflammation
Interventions
First Posted Date
2016-10-21
Last Posted Date
2020-10-14
Lead Sponsor
Rigshospitalet, Denmark
Registration Number
NCT02941016
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia

Phase 3
Completed
Conditions
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Interventions
Drug: Placebo
First Posted Date
2016-07-14
Last Posted Date
2022-07-22
Lead Sponsor
Amgen
Target Recruit Count
467
Registration Number
NCT02833844
Locations
🇬🇧

Research Site, London, United Kingdom

Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

Phase 3
Completed
Conditions
Subjects With Hyperlipidemia, Dyslipidemia
Interventions
Drug: Placebo
First Posted Date
2016-04-06
Last Posted Date
2022-09-23
Lead Sponsor
Amgen
Target Recruit Count
129
Registration Number
NCT02729025
Locations
🇳🇱

Research Site, Waalwijk, Netherlands

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

Phase 3
Completed
Conditions
Heterozygous Familial Hypercholesterolemia
Interventions
Drug: Placebo
First Posted Date
2015-03-19
Last Posted Date
2022-11-08
Lead Sponsor
Amgen
Target Recruit Count
158
Registration Number
NCT02392559
Locations
🇬🇧

Research Site, London, United Kingdom

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

Phase 3
Completed
Conditions
Hyperlipidemia
Interventions
Other: Placebo to Ezetimibe
Other: Placebo to Evolocumab
First Posted Date
2013-11-14
Last Posted Date
2018-11-29
Lead Sponsor
Amgen
Target Recruit Count
511
Registration Number
NCT01984424
Locations
🇬🇧

Research Site, Newcastle upon Tyne, United Kingdom

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