Alirocumab (Praluent®): A Comprehensive Monograph on a First-in-Class PCSK9 Inhibitor for Hypercholesterolemia and Cardiovascular Risk Reduction

1.0 Executive Summary

Alirocumab is a first-in-class, fully human monoclonal antibody that represents a significant advancement in lipid-lowering therapy. It functions by potently and selectively inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9), a key regulator of cholesterol homeostasis.[1] Administered via subcutaneous injection, Alirocumab offers a novel therapeutic mechanism that complements and extends beyond the capabilities of traditional oral agents like statins.[4] Its development and approval have provided a powerful new tool for managing dyslipidemia and reducing cardiovascular risk.

The clinical impact of Alirocumab was definitively established in the landmark ODYSSEY OUTCOMES trial. In a high-risk population of patients with a recent acute coronary syndrome (ACS), Alirocumab, when added to high-intensity statin therapy, significantly reduced the risk of major adverse cardiovascular events (MACE). Notably, the trial also demonstrated a statistically significant reduction in all-cause mortality, a finding that solidified its role not merely as a potent low-density lipoprotein cholesterol (LDL-C)-lowering agent but as a vital therapy for the secondary prevention of cardiovascular disease.[2]