Amgen announces top-line results from Phase III trial of evolocumab

USA-based Amgen (Nasdaq: AMGN), the world's leading independent biotech firm, announced that the Phase III LAPLACE-2 trial evaluating evolocumab (AMG 145) in combination with statin therapy in patients with high cholesterol met its co-primary endpoints.

The LAPLACE-2 trial evaluated safety, tolerability and efficacy of evolocumab in combination with statin therapy compared to placebo and ezetimibe in 1,896 patients with high cholesterol. Patients were randomized to one of 24 treatment groups to compare subcutaneous evolocumab (140mg every two weeks or 420mg monthly) with subcutaneous placebo (every two weeks or monthly) or ezetimibe (10mg daily) when added to different daily doses of statin therapies. It achieved the endpoints of the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.

The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the published results observed for the same doses in the Phase 2 LAPLACE-TIMI 57 trial for evolocumab compared to placebo; and in the Phase 2 MENDEL study for evolocumab compared to ezetimibe, published in December (The Pharma Letter December 18, 2013).