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Positive Phase III Results Reported for Evolocumab in Patients With High Cholesterol
Study meets co-endpoints of LDL cholesterol reduction (December 17)
Positive results have been reported from the phase III MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2) trial of evolocumab (Amgen). The study met its co-primary endpoints: 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.
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 LDL-C from the blood.
The MENDEL-2 trial evaluated the safety, tolerability, and efficacy of evolocumab in 614 patients with high cholesterol (LDL-C ≥ 100 mg/dL and < 190 mg/dL) who were not receiving lipid-lowering therapy. The patients were randomly assigned to one of six treatment groups to compare two dosing regimens of evolocumab (140 mg every two weeks or 420 mg monthly) with placebo and ezetimibe (10 mg daily).
According to the Centers for Disease Control and Prevention (CDC), more than 71 million adults in the U.S. have high LDL-C levels. Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.
Source: Amgen; December 17, 2013.