Amgen reports more Phase III AMG 145 data

Amgen Inc. (NASDAQ:AMGN) reported data on Thursday from its second Phase III trial evaluating subcutaneous evolocumab ( AMG 145) to treat hyperlipidemia. In the DESCARTES trial, once-monthly evolocumab plus background lipid-lowering therapy met the primary endpoint of a greater percent reduction in LDL-C from baseline to week 52 vs. placebo plus background therapy. The double-blind, international trial enrolled 901 patients with fasting LDL-C levels of 75 mg/dL or greater and fasting triglycerides of 400 mg/dL or lower. Patients' background lipid-lowering therapies included diet alone, diet plus atorvastatin and diet plus atorvastatin and ezetimibe.

On Tuesday, Amgen reported that evolocumab met the co-primary endpoints in the Phase III MENDEL-2 trial to treat hyperlipidemia in patients who were not receiving lipid-lowering therapy (see BioCentury, Dec. 17). ...