Data from Phase II and III studies confirms positive evolocumab effect in lowering LDL-C- Amgen

Amgen has announced new data from three separate analyses of Phase II and III studies evaluating evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication for the treatment of Dyslipidaemia.

Data from one of the long-term pooled analyses showed that evolocumab significantly reduced lipoprotein(a) (Lp(a)) over 64 weeks. Data from a separate long-term, 52-week pooled analysis showed that adverse events (AEs) were overall balanced between patients who achieved LDL-C levels of <40 mg dl and those who achieved ldl-c levels of>40 mg/dL. Another pooled analysis showed the two dosing regimens of evolocumab were clinically equivalent. These evolocumab data were included as part of the 13 presentations showcased at the American Heart Association (AHA) Scientific Sessions 2014.

Analysis of pooled data from Phase II, III and open-label extension studies of 3,278 patients with high cholesterol showed that in the year-long extension phase, treatment with subcutaneous evolocumab 140 mg every two weeks or 420 mg monthly plus standard of care (SOC) resulted in mean reductions in Lp(a) from baseline of 22 percent at 24 weeks and 29 percent at 52 weeks. The mean Lp(a) reductions showed consistency with results observed in the 12-week parent studies, indicating treatment with evolocumab resulted in significant and sustained reductions in Lp(a) over a combined period of 64 weeks (p<0.001). lpa is a pro-atherogenic lipoprotein related to ldl and is associated with cardiovascular disease risk.>