Alirocumab licence extended to reducing risk in atherosclerotic CVD

The European Commission has approved an extension to the marketing authorisation for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab (Praluent), to include adults with atherosclerotic cardiovascular disease in order to reduce cardiovascular risk.

Alirocumab is a monoclonal antibody lipid-lowering therapy that binds selectively to PCSK9, preventing it from binding to LDL receptors on the surface of liver cells, thus inhibiting LDL receptor degradation and increasing hepatic LDL cholesterol uptake from the circulation. It is administered either fortnightly or monthly by subcutaneous injection.

Alirocumab has been licensed since 2015 for the treatment of patients with primary hypercholesterolaemia and mixed dyslipidaemia. The licence extension means it is now also authorised for use in patients with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL cholesterol levels, either in combination with the maximum tolerated dose of a statin (with or without other lipid-lowering therapies); or alone or in combination with other lipid-lowering therapies in patients who cannot take a statin.

The licence extension follows on from the results of the ODYSSEY OUTCOMES trial, which showed that alirocumab can significantly reduce the risk of subsequent cardiovascular events in high-risk patients with existing cardiovascular disease. Alirocumab reduced the risk of major adverse cardiovascular events by 15% compared with placebo in patients with acute coronary syndrome (ie heart attack or unstable angina) on intensive or maximum-tolerated statin therapy.

The other PCSK9 inhibitor on the market, evolocumab, was given a licence extension for established atherosclerotic cardiovascular disease in May 2018.


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