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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 a monoclonal antibody being developed for primary hypercholesterolemia, a condition of elevated cholesterol levels. It is also being studied in mixed dyslipidemia, which involves abnormal levels of lipids in the blood. The drug is administered in a home setting using either an automated mini-doser or a prefilled autoinjector/pen.
Evolocumab AMD is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's use in patients with primary hypercholesterolemia and mixed dyslipidemia.
Evolocumab AMD is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for its efficacy and safety in the intended patient population.
Evolocumab AMD is associated with one completed Phase 3 clinical trial, identified as NCT01879319. This study assessed in-home use of the drug administered via an automated mini-doser or a prefilled autoinjector/pen. The trial enrolled 164 participants with primary hypercholesterolemia or mixed dyslipidemia and was conducted in the United States and Canada.
Evolocumab AMD is a formulation of evolocumab, a monoclonal antibody targeting PCSK9. The 'AMD' designation refers to the specific delivery method being studied, which includes an automated mini-doser or a prefilled autoinjector/pen for home administration. This distinguishes it from other formulations of the same drug.