AMG 145 meets endpoint in Phase III trial for Dyslipidaemia-Amgen

The Phase III DESCARTES study evaluating the long-term 52-week safety and efficacy of AMG 145 (evolocumab), from Amgen, for the treatment of Dyslipidaemia met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52. The mean percent reduction in LDL-C, or "bad" cholesterol, was consistent with the results observed in the 52-week analysis of the Phase II OSLER study. Evolocumab significantly reduced LDL-C, as measured by the accepted standard, preparative ultracentrifugation, from baseline at week 52 compared to placebo. LDL-C reduction at week 12 was consistent with the long-term efficacy at week 52.

Safety was balanced across treatment groups. The most common adverse events (more than 5% in evolocumab) were nasopharyngitis, upper respiratory tract infection, influenza and back pain. Details of the DESCARTES study results will be submitted to a future medical conference and for publication.