EC clears alirocumab for patients with CV risk

May 8, 2019 0 By FM

The European Commission (EC) has approved a new indication for alirocumab (Praluent) to reduce cardiovascular risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors.

ASCVD is an umbrella term, defined as a buildup of plaque in the arteries that can lead to reduced blood flow and a number of serious conditions such as stroke, peripheral artery disease and acute coronary syndrome (ACS), which includes heart attack and unstable angina.

The EC approval is based on data from ODYSSEY OUTCOMES, a phase 3 trial that assessed the effect of adding alirocumab to maximally-tolerated statins in 18,924 patients who had an ACS between 1-12 months before enrolling in the trial.

Alirocumab is the only PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor available in two starting doses as a single 1 milliliter injection (75 mg and 150 mg) once every two weeks and can also be administered as 300 mg once every four weeks enabling physicians to tailor treatment based on an individual patient’s LDL-C-lowering needs.

Alirocumab inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood.