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Label indication REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. FDA label
Also known as AMG 145, Repatha
Evolocumab Pre-filled Syringe · 1 trial · 2 indications
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
| Arm | Type | Description |
|---|---|---|
| Evolocumab PFS | EXPERIMENTAL | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| Evolocumab AI/pen | EXPERIMENTAL | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| Name | Type | Description |
|---|---|---|
| Evolocumab Pre-filled Syringe | BIOLOGICAL | Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe. |
| Evolocumab AI/pen | BIOLOGICAL | Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen. |
Inclusion Criteria: * Fasting LDL-C at screening \> 85 mg/dL * Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes or poorly...
Evolocumab Pre-filled Syringe is a monoclonal antibody formulation of evolocumab supplied in a prefilled syringe for subcutaneous administration. It is being developed by Amgen Inc. for the treatment of primary hypercholesterolemia, a cardiovascular condition characterized by elevated cholesterol levels.
Evolocumab Pre-filled Syringe is used for the treatment of primary hypercholesterolemia. It is also studied in mixed dyslipidemia. The prefilled syringe presentation is designed to allow patients to administer the medication at home.
Evolocumab Pre-filled Syringe targets PCSK9, a protein that regulates cholesterol levels. By inhibiting PCSK9, the drug increases the clearance of LDL cholesterol from the blood, thereby lowering cholesterol levels in patients with primary hypercholesterolemia.
Evolocumab Pre-filled Syringe is being developed by Amgen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol AMGN.
Evolocumab Pre-filled Syringe is in Phase 3 clinical development. The Phase 3 trial has been completed. It is an investigational product and has not been approved by the FDA for the prefilled syringe presentation.
Evolocumab Pre-filled Syringe has been evaluated in a Phase 3 clinical trial, NCT01849497, titled "Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen." This completed trial enrolled 149 participants in the United States and Canada.