Two fully humanized anti-PCSK9 mAbs are currently approved for the treatment of hypercholesterolemia: (i) evolocumab, (AMG145, trade name Rephata) developed by Amgen (Amgen, Thousand Oaks, CA, USA) and approved by the European Commission in July 2015 and the FDA one month later, and (ii) alirocumab (SAR236553/REGN727, trade name Praluent), developed by Regeneron and Sanofi Pharmaceuticals (Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; Sanofi, Paris, France) and approved by Endocrinology and Metabolic Drugs Advisory Committee (EMDAC) of the US FDA in July 2015. The gene discussed is PCSK9; the disease is familial hypercholesterolemia.