New Repatha analyses show efficacy and safety across risk groups

US biotech major Amgen (Nasdaq: AMGN) today announced data presented at the European Society of Cardiology (ESC) Congress 2016 in Italy showing Repatha(evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH).

"These analyses continue to shape the clinical evidence for Repatha and help to advance our understanding of its potential to benefit patients," said Sean Harper, executive vice president of R&D at Amgen, adding: "The data at ESC provide further insights into the impact of Repatha on multiple patient populations who are at higher cardiovascular risk and are in need of additional treatment options."

Researchers looking at the "efficacy of evolocumab in patients across ESC/EAS CV risk subgroups," categorized a total of 2,532 patients from three, 12-week Phase III studies by the four ESC/European Atherosclerotic Society (EAS) risk criteria (very high, high, moderate and low). The analysis showed that treatment with Repatha 140mg every two weeks or 420mg monthly consistently reduced levels of LDL-C and other lipids from baseline to the mean of weeks 10 and 12 across all risk categories compared to placebo or ezetimibe controls. For example, among very high-risk patients, Repatha reduced LDL-C levels from baseline 65.2% more than placebo and 40.7% more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1%, 50.5% and 40.8% of patients on Repatha, ezetimibe and placebo, respectively.