EVKEEZA
Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated for the treatment of homozygous familial hypercholesterolemia (HoFH). It is used as an adjunct to diet, exercise, and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies. The medication is approved for use in adult and pediatric patients aged 1 year and older.
How EVKEEZA Works
Evinacumab-dgnb is a recombinant human monoclonal antibody that binds to and inhibits ANGPTL3, a protein primarily expressed in the liver that regulates lipid metabolism. By blocking ANGPTL3, the drug rescues the activity of lipoprotein lipase and endothelial lipase, leading to reductions in triglycerides and high-density lipoprotein cholesterol. It reduces LDL-C independently of the low-density lipoprotein receptor by promoting the processing and clearance of very low-density lipoproteins upstream of LDL formation.
Details
- Status
- Prescription
- First Approved
- 2021-02-11
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
EVKEEZA Approval History
What EVKEEZA Treats
1 indicationsEVKEEZA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Homozygous Familial Hypercholesterolemia
Drugs Similar to EVKEEZA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
EVKEEZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)EVKEEZA is indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH). EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH).
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.