Amgen announces three Phase III studies, MENDEL-2, DESCARTES and RUTHERFORD-2 of evolocumab for High Cholesterol
Amgen announced new detailed data 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 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol. Results from the three separate Phase III studies, MENDEL-2, DESCARTES and RUTHERFORD-2, were presented as Featured Clinical Research in a Special Session at the American College of Cardiology's 63rd Annual Scientific Session (ACC.14).
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 (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).
"Anti-PCSK9 Monotherapy for Hypercholesterolemia � The MENDEL-2 Randomized, Controlled Phase 3 Clinical Trial of Evolocumab"- Journal of the American College of Cardiology, In Press, Accepted Manuscript, Available online 29 March 2014Michael J. Koren, Pernille Lundqvist, Michael Bolognese, Joel M. Neutel, Maria Laura Monsalvo, Jingyuan Yang, Jae B. Kim, Rob Scott, Scott M. Wasserman, Harold Bays, MENDEL-2 Investigators.
"A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia"- March 29, 2014Blom D.J., Hala T., Bolognese M., et al.10.1056/NEJMoa1316222.
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