Successful pooled analysis of AMG 145 in Dyslipidaemia

Treatment with AMG 145 from Amgen,resulted in significant reductions in low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, of up to 59% in an efficacy analysis of pooled data from four 12-week Phase II studies evaluating AMG 145 in patient populations with high cholesterol. Results from the efficacy analysis showed mean reductions in LDL-C from baseline to week 12 ranged from 40 to 59% across AMG 145 doses in comparison to 0.1 to 0.5% for placebo (p=0.001). AMG 145 treatment was also associated with improvements in other lipid parameters, including high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1. Adverse events were more frequent with AMG 145 than placebo (57 percent vs. 49 percent); the most frequent being nasopharyngitis. Amgen presented the data at the ESC Congress 2013.

AMG 145 is an investigational human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.