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Repatha®
Repatha® (evolocumab) is a monoclonal antibody that binds to and inhibits PCSK9, allowing increased clearance of LDL cholesterol from the bloodstream.
Repatha® (evolocumab) is a monoclonal antibody that binds to and inhibits PCSK9, allowing increased clearance of LDL cholesterol from the bloodstream. Used for Heterozygous familial hypercholesterolemia (HeFH), Homozygous familial hypercholesterolemia (HoFH), Established cardiovascular disease (atherosclerotic cardiovascular disease) in patients requiring additional LDL lowering.
At a glance
| Generic name | Repatha® |
|---|---|
| Sponsor | Sejong General Hospital |
| Drug class | PCSK9 inhibitor (monoclonal antibody) |
| Target | PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
PCSK9 is a protein that normally degrades LDL receptors on liver cells, reducing the liver's ability to remove LDL cholesterol from blood. By blocking PCSK9, evolocumab increases the number of functional LDL receptors available on hepatocytes, thereby enhancing LDL cholesterol uptake and lowering circulating LDL levels. This mechanism is particularly effective in patients with elevated LDL cholesterol who are already on statin therapy or who are statin-intolerant.
Approved indications
- Heterozygous familial hypercholesterolemia (HeFH)
- Homozygous familial hypercholesterolemia (HoFH)
- Established cardiovascular disease (atherosclerotic cardiovascular disease) in patients requiring additional LDL lowering
Common side effects
- Injection site reactions
- Nasopharyngitis
- Upper respiratory tract infection
- Influenza
- Back pain
- Muscle-related adverse events
Key clinical trials
- A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease
- YN001-004 in Patients With Coronary Atherosclerosis in Australia (PHASE2)
- Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI (PHASE4)
- Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery (PHASE4)
- Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels (PHASE2)
- Evolocumab in STEMI (PHASE3)
- A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease (PHASE2)
- Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI (PHASE4)
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:
- Repatha® CI brief — competitive landscape report
- Repatha® updates RSS · CI watch RSS
- Sejong General Hospital portfolio CI