Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi on Friday jointly announced the receipt of approval from the US Food and Drug Administration (FDA) for Praluent (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

The companies added that the high levels of "bad" cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), increase patients' risk for serious CV including heart attack or stroke. Adults who experience a heart attack or stroke have an approximately one in three chance to have another CV event.

According to the companies, Praluent (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. Praluent is the first PCSK9 (proprotein convertase subtilisin/kexin type 9) and only PCSK9 inhibitor available in two doses with two levels of efficacy as a single 1 ml injection (75 mg and 150 mg) once every two weeks. It can be administered as 300 mg once every four weeks (monthly), enabling physicians to tailor treatment based on an individual patient's LDL-C-lowering needs.

This US FDA approval is based on data from the partnership's ODYSSEY OUTCOMES, which assessed the effect of adding Praluent to maximally-tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial.

In the trial, the primary endpoint included time to first heart attack, stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation. The partnership observed 27% reduced risk of stroke, 14% reduced risk of non-fatal heart attack and 39% reduced risk of unstable angina requiring hospitalisation as well as a 15% reduced risk of death from any cause (also called all-cause mortality.