Evkeeza
Authorised
This medicine is authorised for use in the European Union
evinacumab
MedicineHumanAuthorised
Overview
Evkeeza is a medicine used together with low-fat diet and other medicines to reduce levels of cholesterol in the blood. It is used in adults, adolescents and children aged 5 years and older with homozygous familial hypercholesterolaemia. This is an inherited disease that increases the levels of low-density lipoprotein cholesterol (LDL cholesterol or ‘bad cholesterol’) in the blood, which is a known risk factor for cardiovascular disease.
Evkeeza contains the active substance evinacumab.
Evkeeza can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the treatment of lipid disorders (altered fat levels in the blood). Patients should be on stable doses of other cholesterol-lowering treatments before they can start treatment with Evkeeza.
Evkeeza is given as an infusion (drip) into a vein for 60 minutes every four weeks.
For more information about using Evkeeza, see the package leaflet or contact your doctor or pharmacist.
The active substance in Evkeeza, evinacumab, is a monoclonal antibody (a type of protein) that has been designed to attach to ANGPTL3, a protein that blocks certain lipases (enzymes that break down fats) in the body. Once evinacumab attaches to ANGPTL3, the lipases can function again, which lowers the blood levels of fats and reduces cholesterol.
A main study showed that Evkeeza effectively reduced LDL cholesterol levels in adults and adolescents aged 12 years and older with homozygous familial hypercholesterolaemia. The participants received Evkeeza or placebo (a dummy treatment) while also taking other cholesterol-lowering therapies.
The study involved 65 patients who received either Evkeeza or placebo once every four weeks. After 24 weeks, the average LDL cholesterol levels in the blood of patients receiving Evkeeza had reduced by around 47% from the start of the treatment, compared with about a 2% increase in patients receiving placebo. The improvement in LDL cholesterol levels with Evkeeza was maintained when treatment was given for 24 additional weeks.
An additional main study looked at the effectiveness of Evkeeza in 14 children aged 5 to 11 years with homozygous familial hypercholesterolaemia. In this study, Evkeeza was not compared with another treatment or placebo. After 24 weeks of treatment, Evkeeza lowered LDL cholesterol levels by 48%.
A study in 6 children aged 5 to 11 years showed that Evkeeza acts in the same way in the body of younger children as in that of adolescents and adults.
The most common side effect with Evkeeza (which may affect more than 1 in 10 people) is inflammation of the nose and throat. Other side effects (which may affect up to 1 in 10 people) are flu-like illness, dizziness, back pain and nausea (feeling sick). The most frequent serious side effect (which may affect up to 1 in 100 people) is anaphylaxis (sudden severe allergic reaction).
For the full list of side effects and restrictions of Evkeeza, see the package leaflet.
Two studies showed that adding Evkeeza to other cholesterol-lowering treatments effectively reduced LDL cholesterol levels in the blood of adults and adolescents with homozygous familial hypercholesterolaemia. A third study in children aged 5 to 11 years showed comparable results. However, the long-term benefits for the heart and circulatory system still need to be studied. Side effects with Evkeeza were acceptable, and most patients could receive prolonged treatment (at least one year) without needing to stop.
Although uncertainties remain, the European Medicines Agency therefore decided that Evkeeza’s benefits are greater than its risks, and it can be authorised for use in the EU.
Evkeeza has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about Evkeeza due to the rarity of the disease. Every year, the Agency will review any new information that becomes available, and this overview will be updated as necessary.
Since Evkeeza has been authorised under exceptional circumstances, the company that markets Evkeeza will provide results every year, highlighting the medicine’s long-term safety, outcomes of any pregnancies that occur, and the effect on fatty deposits in the arteries (atherosclerosis). The company that markets Evkeeza will collect these results from an ongoing registry (a collection of information) of patients with homozygous familial hypercholesterolaemia.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Evkeeza have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Evkeeza are continuously monitored. Side effects reported with Evkeeza are carefully evaluated, and any necessary action is taken to protect patients.
Evkeeza received a marketing authorisation valid throughout the EU on 17 June 2021.
This overview was last updated in 12-2023.
Product information
Latest procedure affecting product information: II/0011
11/12/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Evkeeza
- Active substance
- Evinacumab
- International non-proprietary name (INN) or common name
- evinacumab
- Therapeutic area (MeSH)
- Hypercholesterolemia
- Anatomical therapeutic chemical (ATC) code
- C10AX
Pharmacotherapeutic group
Lipid modifying agentsTherapeutic indication
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).
News on Evkeeza
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