Evolocumab Efficacious in Phase 3 Cholesterol Trial

Amgen announced that the Phase 3 MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels-2) trial with evolocumab (AMG 145) met its co-primary endpoints. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.

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The MENDEL-2 trial is a randomized, multi-center, double-blind, double-dummy, stratified, placebo and ezetimibe-controlled parallel group study designed to evaluate the efficacy and safety of evolocumab in 614 hyperlipidemic patients with a 10-year Framingham risk score of 10% or less who were not receiving lipid-lowering therapy. Patients were randomized to one of six treatment groups to compare two dosing regimens of evolocumab (140mg every two weeks or 420mg monthly) with placebo and ezetimibe 10mg daily. The co-primary endpoints were the percent reduction from baseline in 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 compared to placebo and ezetimibe were consistent with results observed in the MENDEL Phase 2 study.

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