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Repatha (EVOLOCUMAB)
Evolocumab, a human monoclonal IgG2, lowers LDL-C by inhibiting PCSK9 binding to LDLR, increasing LDLR availability to clear LDL.
Repatha (Evolocumab) is a PCSK9 inhibitor, a small molecule drug that targets proprotein convertase subtilisin/kexin type 9. It works by binding to PCSK9, preventing it from breaking down LDL receptors, which leads to increased clearance of LDL cholesterol from the bloodstream. Repatha is approved to treat various cardiovascular and lipid disorders, including familial hypercholesterolemia and hypercholesterolemia. As of my knowledge cutoff, Repatha remains a patented product with no generic manufacturers. Key safety considerations include potential injection site reactions and elevated liver enzymes.
At a glance
| Generic name | EVOLOCUMAB |
|---|---|
| Sponsor | Repatha |
| Drug class | PCSK9 Inhibitor [EPC] |
| Target | PCSK9 |
| Modality | Monoclonal antibody |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2015 |
| Annual revenue | 2100 |
Mechanism of action
Evolocumab works by blocking the interaction between PCSK9 and LDL receptors on liver cells. This prevents the degradation of LDL receptors, allowing more receptors to remain on the cell surface to remove LDL cholesterol from the bloodstream, thus reducing LDL-C levels.
Approved indications
- Cardiovascular disease
- Complex dyslipidemia
- Familial hypercholesterolemia - heterozygous
- Familial hypercholesterolemia - homozygous
- Hypercholesterolemia
Common side effects
- nasopharyngitis
- upper respiratory tract infection
- influenza
- back pain
- injection site reactions
- cough
- urinary tract infection
- sinusitis
- headache
- myalgia
- dizziness
- musculoskeletal pain
Key clinical trials
- Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (PHASE2,PHASE3)
- Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects (PHASE3)
- Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 (PHASE3)
- Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study (PHASE3)
- Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders (PHASE3)
- Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2 (PHASE3)
- Real World Adherence of PCSK9 Targeted Therapy
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Repatha CI brief — competitive landscape report
- Repatha updates RSS · CI watch RSS
- Repatha portfolio CI