27 August 2015 -  Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved a new cholesterol-lowering medication, Repatha (evolocumab) injection. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

"We are excited about today's approval of Repatha in the U.S. as patients and physicians will now have a new treatment option to lower LDL cholesterol," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Data from key clinical studies have shown that Repatha significantly reduces LDL cholesterol in patients who have not been able to lower their LDL cholesterol through diet and statins alone. At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease."

For more details, go to: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2082837

MAESTrO Insight: Evolocumab (Repatha) was approved by the European Commission on 17 August 2015.