Evkeeza FDA Approval History
Last updated by Judith Stewart, BPharm on March 23, 2023.
FDA Approved: Yes (First approved February 11, 2021)
Brand name: Evkeeza
Generic name: evinacumab-dgnb
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol, Familial Homozygous
Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH).
- Evkeeza is a fully-human monoclonal antibody that works by binding to and blocking the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism. Evkeeza is the first FDA-approved ANGPTL3 inhibitor.
- Evkeeza is administered via intravenous infusion once a month (every 4 weeks).
- Evkeeza can cause serious side effects including allergic reactions. Common side effects include symptoms of the common cold, flu-like symptoms, dizziness, pain in legs or arms, nausea, and decreased energy.
Development timeline for Evkeeza
Further information
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