New Detailed Data From Three Phase 3 Pivotal Studies Show Amgen's Novel Investigational Cholesterol-Lowering Medicine Evolocumab Significantly Reduced LDL Cholesterol By 55-66 Percent Compared To Placebo In Patients With High Cholesterol
Data From Three Separate Phase 3 Studies of Evolocumab (AMG 145), a PCSK9 Inhibitor, Presented as Featured Clinical Research at ACC.14
THOUSAND OAKS, Calif., March 29, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol. Results from the three separate Phase 3 studies, MENDEL-2, DESCARTES and RUTHERFORD-2, were presented today as Featured Clinical Research in a Special Session at the American College of Cardiology's 63 rd Annual Scientific Session (ACC.14). Data from DESCARTES, the long-term safety and efficacy study, were simultaneously published in the New England Journal of Medicine and data from MENDEL-2, the monotherapy study, were simultaneously published in the Journal of the American College of Cardiology. To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/7061854-amgen-at-american-college-of-cardiology-acc-14-march-29
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. 1 The three Phase 3 studies evaluated evolocumab in different patient populations: as monotherapy in patients with high cholesterol (MENDEL-2); as a long-term 52-week therapy in patients with high cholesterol on risk-based lipid-lowering therapy (DESCARTES); 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 (RUTHERFORD-2).