Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi on Friday jointly announced the receipt of approval from the European Commission (EC) for the new indication for Praluent (alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD).

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

The EC has approved the partnership's Praluent (alirocumab) to reduce cardiovascular (CV) 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.

This EC approval is based on data from the ODYSSEY OUTCOMES, a Phase 3 CV outcomes trial that assessed the effect of adding Praluent to maximally-tolerated statins in 18,924 patients who had an ACS between 1-12 months before enrolling in the trial. The trial met its primary endpoint, showing that Praluent significantly reduced the relative risk of major adverse CV events (MACE) by 15% in patients who had suffered a recent ACS.

According to the companies, Praluent is the only PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor available in two starting doses as a single 1 millilitre (ml) injection (75 mg and 150 mg) once every two weeks and can also be administered as 300 mg once every four weeks (monthly).

In conjunction, the results from the partnership's ODYSSEY OUTCOMES trial were published in The New England Journal of Medicine in 2018. The data from ODYSSEY OUTCOMES have been submitted to the US Food and Drug Administration (FDA), with a target action date of 28 April 2019.