Is Evkeeza FDA approved as a high cholesterol treatment?
Yes, Evkeeza injection is FDA-approved to help lower elevated “bad” (LDL) cholesterol in patients with a rare but serious condition called Homozygous Familial Hypercholesterolemia (HoFH). It is used in adults and children 5 years of age and older.
Evkeeza is given as a monthly intravenous (IV) injection into your vein, either at your doctor’s office, an infusion clinic or at your home. The infusion itself takes about 60 minutes.
When was Evkeeza (evinacumab) approved?
Evkeeza was approved by the FDA in February 2021. It is the first ANGPTL3 (angiopoietin-like 3) inhibitor and is manufactured by Regeneron.
Related: Evkeeza FDA Approval History (in more detail)
What is Evkeeza used for?
Evkeeza (evinacumab-dgnb) is used to treat Homozygous familial Hypercholesterolemia (HoFH). HoFH is a very rare, inherited condition in which patients cannot remove unwanted low-density lipoprotein-cholesterol (LDL-C, also called “bad” cholesterol) from their body.
Patients with HoFH can die from a heart attack or other cardiac event before the age of thirty due to early heart disease (atherosclerosis).
HoFH occurs when you inherit two genes, one from each parent, that leads to dangerous levels of LDL-C in the blood (> 400 mg/dL). It affects about 1,300 patients in the U.S.
Related questions
- What is the mechanism of action for Evkeeza (evinacumab-dgnb)?
- Where can I find the Evkeeza FDA package insert?
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Can I use Evkeeza with my other cholesterol medicines?
Yes, Evkeeza is used along with your current cholesterol-lowering medications, if prescribed by your healthcare provider. Patients in clinical studies were also taking other lipid-lowering agents such as maximally tolerated doses of:
- statins (for example: Lipitor or Crestor)
- ezetimibe (Zetia)
- PCSK9 inhibitors (Repatha or Praluent)
- lomitapide (Juxtapid)
- lipoprotein apheresis
In placebo-controlled clinical studies, Evkeeza has been shown to lower very high LDL cholesterol by almost 50% in a 6 month period, when combined with other cholesterol-lowering treatments. Blood cholesterol levels also dropped an average of 135 mg/dL compared to a drop of 3 mg/dL for those on placebo.
This is not all the information you need to know about Evkeeza (evinacumab-dgnb) for safe and effective use and does not take the place of your doctor’s directions. Review the full Evkeeza information and discuss any questions you have with your doctor or other health care provider.
References
- Raal F, Rosenson R, Reeskamp, L et al. Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med 2020; 383:711-720
DOI: 10.1056/NEJMoa2004215 - Evkeeza (evinacumab-dgnb) prescribing information. 2/2021. Regeneron. Tarrytown, NY. Accessed Dec. 21, 2022 at https://www.regeneron.com/downloads/evkeeza_pi.pdf
- Evkeeza.com. Regeneron. Accessed Dec. 21, 2022 at https://www.evkeeza.com/s/faq
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Drug information
- Evkeeza Information for Consumers
- Evkeeza prescribing info & package insert (for Health Professionals)
- Side Effects of Evkeeza (detailed)
Related support groups
- Evkeeza (3 questions, 3 members)
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