PRALUENT
Praluent (alirocumab) is a PCSK9 inhibitor indicated to reduce the risk of major adverse cardiovascular events, including 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 or homozygous familial hypercholesterolemia. Furthermore, the treatment is approved for adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.
How PRALUENT Works
Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). Under normal physiological conditions, PCSK9 binds to low-density lipoprotein receptors (LDLR) on the surface of liver cells to promote their degradation. By inhibiting the binding of PCSK9 to these receptors, alirocumab increases the number of available LDLRs to clear LDL from the blood, thereby lowering LDL-C levels.
Details
- Status
- Prescription
- First Approved
- 2015-07-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PRALUENT Approval History
What PRALUENT Treats
4 indicationsPRALUENT 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 risk reduction in adults
- Hypercholesterolemia in adults
- Heterozygous familial hypercholesterolemia in adults and pediatric patients (8 years and older)
- Homozygous familial hypercholesterolemia in adults
PRALUENT 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.
PRALUENT 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.
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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.
PRALUENT FDA Label Details
ProIndications & Usage
FDA Label (PDF)PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) 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 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH). PRALUENT is a proprotein convertase subtilisin kexin type 9...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.