Amgen Presents Phase 3 Pivotal Data For Evolocumab At ACC.14
Amgen announced that it will present Phase III pivotal data from five clinical studies assessing evolocumab (AMG 145) in patients with increased low-density lipoprotein cholesterol (LDL-C) levels. The company will present the data in three Featured Clinical Research and two Late-Breaking Clinical Trial sessions at the upcoming American College of Cardiology's 63rd Annual Scientific Session (ACC.14) to be held in Washington, D.C.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said, “We are eager to share the detailed findings from our Phase 3 cholesterol-lowering studies of evolocumab at ACC. The robust data from these studies in more than 4,000 patients form the basis of our global filing plan and we look forward to potentially providing a new treatment option to improve the lives of patients with high cholesterol, who have increased LDL-C levels despite existing therapies.”
Evolocumab is an investigative fully human monoclonal antibody designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein implicated in lowering the liver’s ability to remove LDL-C from the blood. The drug works by binding to PCSK9 and hindering it from binding to LDL receptors on the liver surface. When PCSK9 proteins are absent, more LDL receptors on the liver surface are present to remove LDL-C from the blood. The drug is currently under development by Amgen scientists.
“Among the abstracts are five oral presentations from the large and comprehensive evolocumab clinical trial program, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations). Data from three Phase 3 studies will be presented in a Featured Clinical Research session on Saturday, March 29, at 2 p.m. EDT and results from two Phase 3 studies will be featured in a Late-Breaking Clinical Trials session on Sunday, March 30, at 8 a.m. EDT.,” stated Amgen in its press release.
The company said the data will form the basis for its global filing plan for evolocumab.