Evolocumab: Additional Phase III data

Additional data from the double-blind, international Phase III RUTHERFORD-2 trial in 329 patients with heFH showed that subcutaneous evolocumab led to placebo-adjusted mean percent reductions in LDL-C from baseline to weeks 10 and 12, a co-primary endpoint, of 66% at the once-monthly 420 mg dose and of 60% at the 140 mg given 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 a placebo-adjusted reduction of 61% at the once-monthly 420 mg dose and of 59% at the 140 mg given every 2 weeks dose (p<0.001 for both). There were no reports of any neurocognitive adverse events in patients receiving evolocumab in the trial. RUTHERFORD-2 enrolled patients with heFH and an LDL-C of >100 mg/dL who were on a stable dose of statin therapy and lipid-lowering medication. Data were presented at the American College of Cardiology meeting in Washington, D.C. In January, Amgen reported top-line data from RUTHERFORD-2 showing that evolocumab met the co-primary endpoints (see BioCentury, Feb. 3). ...