Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi Monday jointly announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) positive opinion for Praluent (alirocumab) Injection to reduce cardiovascular risk in adults with atherosclerotic cardiovascular disease (ASCVD), a build-up of plaque in the arteries that can lead to reduced blood flow,stroke, peripheral artery disease and acute coronary syndrome.

According to the partnership, Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) 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.

The companies said the European Medicines Agency's CHMP has recommended a new indication for Praluent (alirocumab) Injection to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of risk factors in adults with established atherosclerotic cardiovascular disease.

In conjunction, the EMA's CHMP opinion is based on data from the partnership's ODYSSEY OUTCOMES, a Phase 3 cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an ACS between 1-12 months (median 2.6 months) before enrolling in the trial. Approximately 90% of patients were on a high-intensity statin. The European Commission is expected to make a final decision in the coming months.

Currently, theresults of ODYSSEY OUTCOMES are under evaluation by several regulatory authorities worldwide. To date, only the CHMP has completed its assessment. 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.

Additionally, the results from the ODYSSEY OUTCOMES trial were published in The New England Journal of Medicine in 2018, concluded the partnership.