What is the mechanism of action for Evkeeza (evinacumab-dgnb)?
Evkeeza (evinacumab-dgnb) is a fully-human monoclonal antibody that works by blocking the action of a protein called angiopoietin-like 3 (ANGPTL3). When Evkeeza blocks the action of ANGPTL3, "bad" cholesterol (known as LDL cholesterol) can be cleared from the body in patients with Homozygous Familial Hypercholesterolemia (HoFH).
Regeneron’s Evkeeza was approved in February 2021 and is the first FDA-approved ANGPTL3 inhibitor. In studies, Evkeeza has been shown to lower very high LDL cholesterol by up to 50% in 6 months, compared to a placebo, when combined with other cholesterol-lowering treatments.
How is Evkeeza administered?
Evkeeza is given by a 60 minute intravenous (IV) infusion into a vein once a month (every 4 weeks), either at your doctor’s office, an infusion clinic or at your home. The recommended dose is 15 milligrams per kilogram (mg / kg) of body weight in adults and children 5 years and older.
The LDL-lowering effect of Evkeeza can be assessed as early as 2 weeks after initiation.
Why is Evkeeza prescribed?
Evkeeza is used in addition to other cholesterol lowering therapies to treat Homozygous Familial Hypercholesterolemia (HoFH) in adults and children 5 years of age and older. It is not known if Evkeeza is safe and effective in people with other types of high cholesterol.
HoFH is a rare but very serious inherited condition that limits the body’s ability to remove unwanted “bad” cholesterol (low-density lipoprotein-cholesterol or LDL-C). Extremely high levels of bad cholesterol in patients with HoFH often lead to a heart attack and death before the age of 30.
The effect of Evkeeza on heart problems such as heart attacks, stroke, or death is not known.
Are Evkeeza side effects serious?
Evkeeza can cause serious side effects including allergic reactions and anaphylaxis (severe or life-threatening allergic reaction).
Common side effects (occurring in at least 5% of patients) include:
- symptoms of the common cold (nasopharyngitis)
- infuenza (flu) like symptoms
- dizziness
- runny nose
- pain in legs or arms
- nausea
- decreased energy / fatigue
If you have any side effects that bother you or don’t go away, contact your healthcare provider.
Learn more: Side effects and warning for Evkeeza (in more detail)
Related questions
- Is Evkeeza FDA approved as a high cholesterol treatment?
- Where can I find the Evkeeza FDA package insert?
- What are the 10 most effective ways to lower cholesterol?
How much does Evkeeza cost?
Evkeeza is an expensive medicine that costs about $11,800 for a supply of 2.3 milliliters (150 mg/mL) or $41,076 for a supply of 8 milliliters (150 mg/mL). You will receive this medicine in a clinic, doctor’s office or at home. Your dose will be based on your weight. There may be additional costs related to clinic administration or nursing support.
Eligible patients may be able to pay as little as $0 (up to $25,000 maximum per year) with the myRARE Copay card for Evkeeza. You may qualify for the copay card if you have a valid prescription and private or commercial insurance (but not government insurance like Medicare, Medicaid, and TRICARE), and live in the 50 US states, District of Columbia, or Puerto Rico. There are no income restrictions to qualify for this plan.
- Your healthcare provider and Regeneron’s myRARE Patient Support Program will work with you to determine insurance or patient assistance eligibility and fill out the necessary paperwork to gain access to this treatment.
- This program can also provide infusion education from a nurse or pharmacist, appointment reminders, and help with finding community support.
- Call 1-877-EVKEEZA (1-877-385-3392) to learn more.
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
- Evkeeza (evinacumab-dgnb) prescribing information. 3/2023. Regeneron. Tarrytown, NY. Accessed Mar 24, 2023 at https://www.regeneron.com/downloads/evkeeza_pi.pdf
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