EC approves Amgen's PCSK9 inhibitor

Amgen Inc. (NASDAQ:AMGN) said the European Commission approved an MAA for Repatha evolocumab to treat several groups of patients with high cholesterol. The approval is the first anywhere for a PCSK9 inhibitor.

Repatha is approved for adults with primary hypercholesterolemia -- including heterozygous familial (HeFH) or non-familial hypercholesterolemia -- or mixed dyslipidemia, as an adjunct to diet in combination with a statin or other therapies in patients unable to reach LDL-C goals on statins alone; or alone or in combination with other lipid-lowering therapies in patients who cannot take statins. ...