ACC 2014: Amgen's evolocumab reduces cholesterol by up to 66%

USA-based Amgen (Nasdaq: AMGN) announced data at the American College of Cardiology 63rd Annual Scientific Session this weekend from three Phase III studies that showed treatment with its novel investigational cholesterol-lowering medication evolocumab (AMG 145) resulted in a statistically significant reduction of 55%-66% in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol.

Evolocumab is an investigational fully-human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood. The three Phase III studies evaluated evolocumab in different patient populations: as monotherapy in patients with high cholesterol in the MENDEL-2 trial, which announced positive results in December; as a long-term 52-week therapy in patients with high cholesterol on risk-based lipid-lowering therapy (in the DESCARTES trial); and in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia (HeFH), a genetic disorder characterized by elevated LDL-C levels (in the RUTHERFORD-2 trial). Analysts quoted by Reuters have forecast annual sales of at least $3 billion for the drug if approved.

Regulatory filing on horizon