First marketing approvals granted for two anti-PCSK9 antibody therapeutics

Two human antibodies targeting proprotein convertase subtilisin/kexin type 9 have been granted first marketing approvals. On July 17, 2015, evolocumab (Repatha^®), a human IgG2 antibody, was approved in the EU to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins, and to treat homozygous familial hypercholesterolemia. Alirocumab (Praluent^®), a human IgG1 antibody, was approved by the US Food and Drug Administration (FDA) on July 24, 2015 for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. FDA also approved evolocumab on August 27, 2015.