Given the large number of clinical trials of PCSK9 mAbs demonstrating efficacy and safety for lipid lowering (51–53), the US Food and Drug Administration and the European Medicines Agency approved evolocumab and alirocumab, two PCSK9 mAbs, in 2015 for LDLc lowering, particularly in patients with familial hypercholesterolemia (FH). This evidence concerns the gene PCSK9 and familial hypercholesterolemia.