Skip to main content

Evkeeza FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

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 12 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.
  • 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

Feb 11, 2021Approval  FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia
Aug 19, 2020New England Journal of Medicine Publishes Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol
Aug 12, 2020FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
Mar 30, 2020Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol
Aug 14, 2019Regeneron Announces Positive Topline Results from Phase 3 Trial of Evinacumab in Patients with Severe, Inherited Form of High Cholesterol

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.