Evkeeza (evinacumab-dgnb)
An approved treatment for Homozygous Familial Hypercholesterolemia.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Evinacumab-dgnb wherever you encounter it, plus the key facts at a glance.
- Generic name
- Evinacumab-dgnb
- Brand name
- Evkeeza
- Development code
- REGN1500
- Drug class
- ANGPTL3 inhibitor (monoclonal antibody)
- Manufacturer
- Regeneron
- How it's taken
- Given by a healthcare provider as an IV infusion over 60 minutes once every 4 weeks, at 15mg/kg of body weight.
A monthly IV infusion that lowers LDL cholesterol in homozygous familial hypercholesterolemia (HoFH), added to diet and other cholesterol medicines. It is approved for adults and children 1 year and older, and in its main trial it roughly halved LDL cholesterol.
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Where Evinacumab-dgnb fits
One of the few HoFH medicines that work without needing LDL receptors, along with Juxtapid, which makes it useful for people with little or no receptor function. It is added to statins, ezetimibe, PCSK9 drugs, Juxtapid or apheresis rather than replacing them.
How Evinacumab-dgnb works
In HoFH, both copies of a gene for clearing LDL cholesterol are faulty, so LDL builds up to very high levels from birth. Most cholesterol drugs work by boosting LDL receptors, which people with HoFH may barely have. Evinacumab blocks ANGPTL3, a protein that holds back the enzymes that break down blood fats. That lowers LDL cholesterol even when LDL receptors are not working.
Side effects and safety
- Serious allergic reactions. Anaphylaxis happened in 1 person (1%) in the trials. Stop the infusion and treat right away if it happens.
- Harm to an unborn baby. A pregnancy test may be done before starting, and birth control is used during treatment and for at least 5 months after the last dose.
- LDL cholesterol, which can drop within 2 weeks
- Watch for allergic reactions during the infusion
Evkeeza has no boxed warning, but it must not be used by anyone who has had a serious allergic reaction to it, and anaphylaxis happened in 1 person in the trials. It can harm an unborn baby, so birth control is used during treatment and for at least 5 months after. Infusion reactions affected 7% of people against 4% on placebo. The most common side effects were cold symptoms, flu-like illness, dizziness, runny nose and nausea.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Evinacumab-dgnb
Given by a healthcare provider as an IV infusion over 60 minutes once every 4 weeks, at 15mg/kg of body weight. It is added to diet, exercise and other cholesterol-lowering treatment, and it can be given regardless of when apheresis, a blood-filtering treatment, is scheduled. A missed dose is given as soon as possible, and monthly dosing restarts from that date.
Availability and cost
Only available as the brand-name product.
Help paying for Evkeeza
The maker of Evkeeza publishes no copay card, but its support program can check your insurance and explain any help that exists. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE. Pick your insurance below to see which offers fit you.
- Insurance and case manager help
Regeneron says myRARE offers financial assistance to eligible patients, insurance benefit verification, community connections and appointment reminders.
The official page does not say who qualifies. Ask the program. · source
Good to know: Call 1-833-EVKEEZA (1-833-385-3392). Copay limits and exclusions were not published on a page we could check; ask the program.
Access and eligibility
Approved for homozygous familial hypercholesterolemia in adults and children 1 year and older, added to diet, exercise and other LDL-lowering treatment. It is not used by anyone who has had a serious allergic reaction to it.
Source: Regeneron myRARE (Evkeeza support)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
In ELIPSE-HoFH (NCT03399786), 65 people with HoFH already on other cholesterol medicines were randomly assigned to Evkeeza or placebo. After 24 weeks, LDL cholesterol fell 47% on Evkeeza and rose 2% on placebo, from an average start of 255mg/dL. The gap had less than a 1 in 10,000 chance of being a fluke. In children aged 5-11 (NCT04233918), LDL fell 48%, and in 6 children aged 1-4 treated through expanded access, a way to get a drug outside a trial, it fell 60% by week 40.
Development history
Regeneron won FDA approval on February 11, 2021 for people 12 and older with HoFH. The age dropped to 5 on March 21, 2023, and to 1 year on September 25, 2025, when the FDA also removed the label's limits-of-use statements. Its trials measured LDL cholesterol, not heart attacks or strokes.
Explore Homozygous Familial Hypercholesterolemia trials
Common questions about Evinacumab-dgnb
▸What is Evinacumab-dgnb (Evkeeza)?
A monthly IV infusion that lowers LDL cholesterol in homozygous familial hypercholesterolemia (HoFH), added to diet and other cholesterol medicines. It is approved for adults and children 1 year and older, and in its main trial it roughly halved LDL cholesterol.
▸How does Evinacumab-dgnb work?
In HoFH, both copies of a gene for clearing LDL cholesterol are faulty, so LDL builds up to very high levels from birth. Most cholesterol drugs work by boosting LDL receptors, which people with HoFH may barely have. Evinacumab blocks ANGPTL3, a protein that holds back the enzymes that break down blood fats. That lowers LDL cholesterol even when LDL receptors are not working.
▸What are the side effects of Evinacumab-dgnb?
Evkeeza has no boxed warning, but it must not be used by anyone who has had a serious allergic reaction to it, and anaphylaxis happened in 1 person in the trials. It can harm an unborn baby, so birth control is used during treatment and for at least 5 months after. Infusion reactions affected 7% of people against 4% on placebo. The most common side effects were cold symptoms, flu-like illness, dizziness, runny nose and nausea.
▸How is Evinacumab-dgnb taken?
Given by a healthcare provider as an IV infusion over 60 minutes once every 4 weeks, at 15mg/kg of body weight. It is added to diet, exercise and other cholesterol-lowering treatment, and it can be given regardless of when apheresis, a blood-filtering treatment, is scheduled. A missed dose is given as soon as possible, and monthly dosing restarts from that date.
▸Is Evinacumab-dgnb FDA approved?
Yes, Evinacumab-dgnb (Evkeeza) is FDA approved (2021) for the treatment of Homozygous Familial Hypercholesterolemia.
▸Can young children with HoFH take Evkeeza?
Yes, since September 25, 2025 it is approved from age 1. In 6 children aged 1-4 treated through expanded access, LDL cholesterol fell about 60% by week 40.
▸Does Evkeeza replace statins or apheresis?
No, it is added to diet, exercise and other cholesterol treatment, including apheresis. It can be given on any schedule relative to apheresis sessions.
▸Who makes Evkeeza?
Evkeeza is made by Regeneron, whose myRARE support program at 1-833-385-3392 helps with insurance and financial assistance for eligible patients.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2025-09-25. EVKEEZA (evinacumab-dgnb) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73412138-6d8f-4ea6-bb72-a740190470ff
- U.S. Food and Drug Administration · 2021-02-11. BLA 761181 approval letter. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761181Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2025-09-25. BLA 761181 supplement S-002 approval letter (age 1 and older). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761181Orig1s002ltr.pdf
- ClinicalTrials.gov. ELIPSE-HoFH: evinacumab in homozygous familial hypercholesterolemia. https://clinicaltrials.gov/study/NCT03399786
- Regeneron · 2025-09-26. EVKEEZA (evinacumab-dgnb) approved in US for children aged 1 and older. https://investor.regeneron.com/news-releases/news-release-details/evkeezar-evinacumab-dgnb-angptl3-antibody-approved-us-children