European regulators have approved a new indication for Regeneron and Sanofi’s Praluent, allowing its use to cut cardiovascular risk in adults with established atherosclerotic CV disease (ASCVD).

ASCVD is defined as a build-up 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.

Praluent (alirocumab) works by inhibiting the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor which increases the number of available LDL receptors on the surface of liver cells to clear LDL, lowering LDL-C levels in the blood.

The ODYSSEY OUTCOMES 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. MACE occurred in 903 patients (9.5%) in the Praluent group and in 1,052 patients (11.1%) in the placebo group.

"Despite treatment with the current standard of care, including statins, many Europeans with established cardiovascular disease are still unable to control their cholesterol," said George Yancopoulos, president and chief scientific officer at Regeneron.

“In the large, prospective ODYSSEY OUTCOMES clinical trial, Praluent reduced the risk of major cardiovascular events, including heart attack, stroke and unstable angina, and was associated with reduced death from any cause."