PCSK9 approvals in Europe
Two agents in a new cholesterol-lowering class – the PCSK9 inhibitors, which use human monoclonal antibodies to target PCSK9 (proprotein convertase subtilisin/kexin type 9) – have received European approval for lowering cholesterol.
Evolocumab (Repatha®, Amgen) is the first PCSK9 inhibitor to be granted marketing authorisation by the European Commission (EC) for use in people with primary hypercholesterolaemia or mixed dyslipidaemia, or in homozygous familial hypercholesterolaemia, who are unable to reach low-density lipoprotein cholesterol (LDL-C) goals with an optimal dose of statin (or a statin and other lipi