The U.S. FDA has approved Praluent (alirocumab) injection for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease (ASCVD) such as heart attacks or strokes, who require additional lowering of LDL (low-density lipoprotein) cholesterol.  Alirocumab is discovered by Regeneron Pharmaceuticals, a biopharmaceutical company based in Tarrytown, NY, and currently being co-developed with global pharmaceutical company Sanofi.  It is a fully humanized monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), a major regulator in cholesterol homeostasis.  PCSK9 inhibitors are a new class of cholesterol-lowering drugs and alirocumab represents the first and the only PCSK9 inhibitor approved by the FDA.  HeFH is a genetic disorder characterized by high levels of LDL cholesterol.  High level of LDL cholesterol is associated with cardiovascular disease, the number one cause of death in the US.  Alirocumab offers another treatment option for patients with HeFH or ASCVD who have not been able to control their LDL cholesterol with diet and statin therapy.


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