EC approves Amgen’s Repatha, the first PCSK9 Inhibitor to be cleared for marketing

21 July 2015

US biotech major Amgen (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorization for Repatha(evolocumab).

The drug is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood.Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood,and is recognized as a major risk factor for cardiovascular disease (CVD).

The EC approved Repatha for:

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