REPATHA
Repatha (evolocumab) is a PCSK9 inhibitor indicated to reduce the risk of major adverse cardiovascular events, such as myocardial infarction and stroke, in adults at increased risk. It is also used as an adjunct to diet and exercise to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. Additionally, the medication is approved for adults and pediatric patients aged 10 years and older with heterozygous or homozygous familial hypercholesterolemia.
How REPATHA Works
Evolocumab is a human monoclonal antibody that targets the proprotein convertase subtilisin kexin type 9 (PCSK9) protein. Normally, PCSK9 binds to low-density lipoprotein receptors (LDLR) on the surface of liver cells to promote their degradation. By inhibiting PCSK9, evolocumab increases the number of available LDLRs to clear LDL from the blood, which results in lower circulating LDL-C levels.
Details
- Status
- Prescription
- First Approved
- 2015-08-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
REPATHA Approval History
What REPATHA Treats
4 indicationsREPATHA is approved for 4 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major adverse cardiovascular events in adults at increased risk
- Hypercholesterolemia in adults
- Heterozygous familial hypercholesterolemia (HeFH) in adults and pediatric patients aged 10 years and older
- Homozygous familial hypercholesterolemia (HoFH) in adults and pediatric patients aged 10 years and older
REPATHA Target & Pathway
ProTarget
A protein that promotes degradation of LDL receptors, reducing the liver's ability to clear LDL cholesterol. Blocking PCSK9 increases LDL receptor availability, dramatically lowering LDL cholesterol levels beyond what statins achieve.
REPATHA Competitors
Pro3 other drugs also target PCSK9. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PCSK9). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to REPATHA
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REPATHA FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). REPATHA ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.