Amgen reports more evolocumab data
Amgen Inc. (NASDAQ:AMGN) reported data on Thursday from the Phase III RUTHERFORD-2 trial evaluating evolocumab ( AMG 145) to treat heterozygous familial hypercholesterolemia (heFH) in patients who were on a stable dose of statin therapy and lipid-lowering medication. In the 329-patient trial, subcutaneous evolocumab given monthly and every two weeks each met the co-primary endpoints of a greater percent reduction in LDL-C from baseline to week 12 and a greater mean percent reduction in LDL-C from baseline to weeks 10 and 12 vs. placebo. The RUTHERFORD-2 data are the fifth to be reported by Amgen from the Phase III program for evolocumab, which comprises 13 trials with a combined planned enrollment of >28,000 patients.
On Tuesday, Amgen reported data from a fourth Phase III trial in the program and said it planned to submit global regulatory applications for the human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9) this year (see BioCentury Extra, Jan. 28). ...