The European Commission granted a marketing authorisation valid throughout the European Union for Praluent on 23 September 2015. Praluent is a medicine used to treat adults with primary hypercholesterolaemia and mixed dyslipidaemia. Praluent is to be used together with a low-fat diet, in the following ways:
- in combination with a statin (other cholesterol-lowering medicines), or a statin plus other fat-lowering medicines, in patients who do not adequately respond to the maximum tolerated dose of the statin;
- alone or in combination with other fat-lowering medicines in patients who cannot tolerate or cannot be given statins.
The active substance in Praluent, alirocumab, is a monoclonal antibody. Alirocumab has been designed to attach to a protein called ‘PCSK9’. This protein attaches to cholesterol receptors on the surface of liver cells and causes these receptors to be absorbed and broken down inside the cells. These receptors control blood levels of cholesterol, especially LDL-cholesterol, by removing it from the bloodstream. By attaching and blocking PCSK9, Praluent prevents the receptors from being broken down inside cells and therefore increases the number of these receptors on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream. This helps to reduce the amount of cholesterol in the blood. Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia. Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins. Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for hypercholesterolaemia (ezetimibe). These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment. When given on top of standard treatment or on top of placebo, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe. The most common side effects with Praluent (which may affect up to 1 in 10 people) are injection site reactions such as pain and redness, problems affecting the nose and throat such as colds, and itching. For the full list of side effects and restrictions, see the package leaflet.