Evolocumab: Additional Phase III data

Additional data from the double-blind, placebo- and active-controlled, international Phase III GAUSS-2 trial in 307 statin-intolerant patients with hyperlipidemia showed that subcutaneous evolocumab led to ezetimibe-adjusted mean percent reductions in LDL-C from baseline to weeks 10 and 12, a co-primary endpoint, of 39% at the once-monthly 420 mg dose and of 37% 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, both doses of evolocumab led to an ezetimibe-adjusted reduction of 38% (p<0.001 for both). There were no neurocognitive adverse events in patients receiving evolocumab in the trial. The trial enrolled patients with high cholesterol who could not tolerate effective doses of >=2 different statins due to muscle-related side effects. 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 January, Amgen reported top-line data from GAUSS-2 showing that evolocumab met the co-primary endpoints (see BioCentury, Jan. 27). ...