Last reviewed · How we verify
Evolocumab AI/pen
Evolocumab is a monoclonal antibody that inhibits PCSK9, allowing increased clearance of LDL cholesterol from the bloodstream.
Evolocumab is a monoclonal antibody that inhibits PCSK9, allowing increased clearance of LDL cholesterol from the bloodstream. Used for Hypercholesterolemia (primary and secondary prevention of cardiovascular disease), Familial hypercholesterolemia.
At a glance
| Generic name | Evolocumab AI/pen |
|---|---|
| Also known as | AMG 145, Repatha, AMG-145 |
| Sponsor | Amgen |
| Drug class | PCSK9 inhibitor |
| Target | PCSK9 |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
PCSK9 is a protein that degrades LDL receptors on liver cells, reducing the liver's ability to remove LDL cholesterol from blood. By blocking PCSK9, evolocumab prevents this degradation, allowing more LDL receptors to remain on the cell surface and dramatically increase LDL cholesterol uptake and clearance from circulation.
Approved indications
- Hypercholesterolemia (primary and secondary prevention of cardiovascular disease)
- Familial hypercholesterolemia
Common side effects
- Injection site reactions
- Nasopharyngitis
- Upper respiratory tract infection
- Influenza
Key clinical trials
- EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction (PHASE4)
- Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia (PHASE4)
- Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia (PHASE3)
- Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen (PHASE3)
- Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Evolocumab AI/pen CI brief — competitive landscape report
- Evolocumab AI/pen updates RSS · CI watch RSS
- Amgen portfolio CI