PARAMETER

DATA

Manufacturer

Amgen, Inc.

Indication

REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:

• to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
• As an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).
• As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

Cell Substrate

Human monoclonal antibody (mAb; IgG2)

Manufacturing platform

The manufacture of evolocumab active substance represents a conventional monoclonal antibody production process (fermentation, recovery, purification and viral inactivation/removal steps). 

Dose in vial/final container

• Injection: 140 mg/mL solution in a single-use prefilled syringe
• Injection: 140 mg/mL solution in a single-use prefilled SureClick® autoinjector
• Injection: 420 mg/3.5 mL solution in a single-use Pushtronex® system (on-body infusor with prefilled cartridge)

Dose to patient

• Adults with established CVS disease or primary hyperlipidemia: 140 mg every 2 weeks or 420 mg once monthly.
• HoFH: 420 mg once monthly.

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

PHASE 2: Primary Hyperlipidemia and Mixed Dyslipidemia

NCT01375777

2

411

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

United States, Australia, Belgium, Canada, Denmark

NCT01380730

2

631

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment with PCSK9 monoclonal Antibody Inhibition Combined with Statin therapy

United States, Canada, Czechia, Denmark, Hungary

NCT01375751

2

168

Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

-

NCT01375764

2

160

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

United States, Spain, Australia, Belgium, Canada, Denmark, Finland, Sweden  

NCT01652703

2

310

A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects

Japan

NCT01439880

2

1324

Open Label Study of Long-Term Evaluation Against LDL-C Trial

United States, Australia, Belgium, Canada, South Africa, Czechia, Japan, Denmark, Finland, Spain, Germany, Hungary, Hong Kong, Norway, Netherlands, Singapore, Sweden, United Kingdom

Phase 3

NCT01763827

3

615

Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

United States, Australia, Belgium, Canada, Denmark, France, Korea, Republic of, South Africa, Taiwan, Turkey

NCT01763866

3

2067

LDL-C Assessment with PCSK9 Monoclonal Antibody Inhibition Combined with Statin Therapy-2

United States, Australia, Belgium, Canada, Hong Kong, France, Czechia, Denmark, Germany, Italy, Hungary, Korea, Republic of, Mexico, Netherlands, Russian Federation, Spain, South Africa, Sweden, Taiwan, Switzerland, United Kingdom

NCT01763905

3

307

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

United States, Australia, Belgium, Canada, Hong Kong, Denmark, France, Germany, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom

NCT01763918

3

331

Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

United States, Australia, Canada, France, Hong Kong, Germany, New Zealand, Netherlands, Norway, South Africa, Spain, Sweden, United Kingdom, Switzerland

NCT01879319

3

164

Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

United States, Canada

NCT01849497

3

149

Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

United States, Canada

NCT01516879

3

905

Durable Effect of PCSK9 Antibody Compared with placebo Study

United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Hungary, South Africa

NCT01854918

3

3681

Open-label Extension Study of Evolocumab (AMG 145) in Adults with Hyperlipidemia and Mixed Dyslipidemia

United States, Australia, Austria, Belgium, Hong Kong, Canada, Czechia, Denmark, France, Italy, Germany, Hungary, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Spain, Poland, South Africa, Taiwan Russian Federation, Sweden, Switzerland, United Kingdom

PHASE 2: HoFH

NCT01588496

2, 3

58

Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities

United States, Belgium, Canada, Czechia, France, Hong Gong, Italy, Spain, New Zealand, Lebanon, Netherlands, South Africa

PHASE 2/3: HoFH and “Severe” HoFH

NCT01624142

2, 3

300

Trial Assessing Long Term Use of PCSK9 Inhibition in Subjects with Genetic LDL Disorders

United States, Australia, Belgium, Brazil, Canada, Czechia, France, Greece, Hong Kong, Israel, Italy, Japan, Lebanon, New Zealand, Netherlands, South Africa, Spain, United Kingdom