Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 AMD · 1 trial · 2 indications
Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.
| Arm | Type | Description |
|---|---|---|
| Evolocumab AMD | EXPERIMENTAL | Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8. |
| Evolocumab AI/pen | EXPERIMENTAL | Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8. |
| Name | Type | Description |
|---|---|---|
| Evolocumab AMD | BIOLOGICAL | Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume. |
| Evolocumab AI/pen | BIOLOGICAL | Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume. |
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 poor...
Evolocumab AMD is being developed for primary hypercholesterolemia, a condition marked by elevated LDL cholesterol. The Phase 3 program also includes patients with mixed dyslipidemia. It is a monoclonal antibody therapy studied in adults aged 18 years and older.
Evolocumab AMD targets PCSK9 and acts as an inhibitor of that protein. By binding PCSK9, the antibody is designed to reduce the degradation of LDL receptors, thereby increasing clearance of LDL cholesterol from the blood. This mechanism underlies its investigation in primary hypercholesterolemia.
Evolocumab AMD is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating the drug in primary hypercholesterolemia and mixed dyslipidemia.
Evolocumab AMD is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
Evolocumab AMD has been studied in the Phase 3 trial NCT01879319, titled "Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen." The trial enrolled 164 adults with primary hypercholesterolemia or mixed dyslipidemia in the United States and Canada and is completed.
Yes, evolocumab AMD is also known as AMG 145. The Phase 3 trial NCT01879319 refers to the drug by both names. AMG 145 is the internal Amgen designation used during development, while evolocumab is the international nonproprietary name.