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Evkeeza (EVINACUMAB)
Evkeeza works by blocking the action of Angiopoietin-related protein 3, a protein that helps regulate cholesterol levels in the blood.
Evkeeza (EVINACUMAB) is a small molecule Angiopoietin-like 3 Inhibitor developed by Regeneron Pharmaceuticals. It targets Angiopoietin-related protein 3 to treat Homozygous Familial Hypercholesterolemia. Evkeeza was FDA-approved in 2021 and is currently owned by Regeneron Pharmaceuticals. As a patented medication, it is not yet available as a generic. Key safety considerations include the need for careful monitoring of patients with a history of thrombotic events.
At a glance
| Generic name | EVINACUMAB |
|---|---|
| Sponsor | Regeneron |
| Drug class | Angiopoietin-like 3 Inhibitor [EPC] |
| Target | Angiopoietin-related protein 3 |
| Modality | Monoclonal antibody |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Evinacumab-dgnb is recombinant human monoclonal antibody that binds to and inhibits ANGPTL3. ANGPTL3 is member of the angiopoietin-like protein family that is expressed primarily in the liver and plays role in the regulation of lipid metabolism by inhibiting lipoprotein lipase (LPL) and endothelial lipase (EL). Evinacumab-dgnb inhibition of ANGPTL3 leads to reduction in LDL-C, HDL-C, and triglycerides (TG). Evinacumab-dgnb reduces LDL-C independent of the presence of LDL receptor (LDLR) by promoting very low-density lipoprotein (VLDL) processing and clearance upstream of LDL formation. Evinacumab-dgnb blockade of ANGPTL3 lowers TG and HDL-C by rescuing LPL and EL activities, respectively.
Approved indications
- Homozygous familial hypercholesterolemia
Common side effects
- Nasopharyngitis
- Influenza like illness
- Dizziness
- Rhinorrhea
- Nausea
- Pain in extremity
- Asthenia
- Infusion site pruritus
- Pyrexia
- Muscular weakness
- Nasal congestion
- Constipation
Key clinical trials
- Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease (PHASE2)
- Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
- Compassionate Use of Evinacumab
- Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia (PHASE3)
- Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia (PHASE3)
- Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia (PHASE3)
- Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis (PHASE2)
- Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
| FDA Orange Book | Patents + exclusivity |