Evkeeza | European Medicines Agency (EMA)

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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 6 months 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 benefits of Evkeeza in children aged from 6 months to less than 5 years were determined following an analysis of data of how the medicine behaves in the body. This included data from older children and adults, along with assumptions about young children’s development and the impact of having homozygous familial hypercholesterolaemia. Results indicated that, although children in this age group have lower blood levels of Evkeeza at the recommended doses, the medicine’s effectiveness in treating homozygous familial hypercholesterolaemia is comparable to that seen in adults and older children. These findings were supported by data from five children who started treatment with Evkeeza before the age of 5 through a compassionate use programme.

For the full list of side effects and restrictions of Evkeeza, see the package leaflet.

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) include 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 (a sudden, severe allergic reaction).

Two studies showed that adding Evkeeza to other cholesterol-lowering treatments effectively reduced LDL cholesterol levels in the blood of adults and children from 12 years of age with homozygous familial hypercholesterolaemia. A third study in children aged 5 to 11 years showed comparable results. The Agency also considered that the effectiveness of Evkeeza in children aged from 6 months to less than 5 years is comparable to that of older children and adults. However, the long-term benefits of treatment 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. The company must provide further data on Evkeeza. It must submit data regarding the medicine’s long-term safety, outcomes of any pregnancies that occur, and the effect of treatment on fatty deposits in the arteries (atherosclerosis). The company will collect these data from an ongoing registry (a collection of information) of patients with homozygous familial hypercholesterolaemia. 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.

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First published: 21/06/2021Last updated: 24/01/2025

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First published: 21/06/2021Last updated: 07/01/2025

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Product information

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(392.17 KB – PDF)

First published: 21/06/2021Last updated: 07/01/2025

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Latest procedure affecting product information:
II/0015

13/12/2024

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).

English (EN)
(61.47 KB – PDF)

First published: 21/06/2021

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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 agents

Therapeutic 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).

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