Evolocumab: Additional Phase III data

Additional data from the double-blind, 6-arm, international Phase III MENDEL-2 trial in 614 patients with high cholesterol (LDL-C of >=100 mg/dL and <190 mg/dL) who were not receiving lipid-lowering therapy showed that subcutaneous evolocumab given once monthly at 420 mg or every 2 weeks at 140 mg led to a placebo-adjusted mean percent reduction in LDL-C from baseline to weeks 10 and 12, a co-primary endpoint, of 57% (p<0.001 for both). Additionally, evolocumab led to ezetimibe-adjusted mean percent reductions in LDL-C from baseline to weeks 10 and 12 of 40% at the once-monthly dose and 39% at the every 2 weeks dose (p<0.001 for both).

On the co-primary endpoint of percent reduction in LDL-C from baseline to week 12, evolocumab led to placebo-adjusted reductions of 55% at the once-monthly dose and 57% at the every 2 weeks dose (p<0.001 for both). Additionally, evolocumab led to ezetimibe-adjusted percent reductions in LDL-C from baseline to week 12 of 38% at the once-monthly dose and 39% at the every 2 weeks dose (p<0.001 for both). There were no neurocognitive adverse events in patients receiving evolocumab in the trial. The trial enrolled patients with a 10-year Framingham risk score of <=10%. Data were published in the Journal of the American College of Cardiology and presented at the American College of Cardiology meeting in Washington, D.C. In December, Amgen reported top-line data from MENDEL-2 showing that evolocumab met the co-primary endpoints (see BioCentury, Dec. 23, 2013). ...