AMG 145 meets endpoint in Phase III trial for HeFH-Amgen
The Phase III RUTHERFORD-2 trial evaluating AMG 145 (evolocumab), from Amgen, in combination with statins and other lipid-lowering therapies in patients with Heterozygous Familial Hypercholesterolemia (HeFH) 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. The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the results observed for the same doses in the Phase II RUTHERFORD trial for evolocumab compared to placebo.
Safety was balanced across treatment groups except for the following most common adverse events (? 2 percent in evolocumab combined group and ? 2 percent compared to placebo): nasopharyngitis (8.6 percent evolocumab; 4.6 percent placebo), contusion (4.1 percent evolocumab; 0.9 percent placebo). Results will be submitted to a future medical conference and for publication.
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