Evkeeza

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).

Before starting treatment with Evkeeza, the patient should be on other cholesterol-lowering treatment.

Evkeeza is given as an infusion (drip) into a vein for 60 minutes every four weeks at a recommended dose of 15 mg per kg of body weight.

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 recognise and attach to a protein called ‘ANGPTL3’. ANGPTL3 can slow down or block enzymes that break down fats. Once attached to ANGPTL3, evinacumab stops the protein from blocking these enzymes, which lowers the 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 main 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% (almost half) 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.

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 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 patients with homozygous familial hypercholesterolaemia. 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.

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.