Phase III trials show Repatha (evolocumab) reduces LDL-C levels in dyslipidaemia with CV risks- Amgen

Amgen has announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups. 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 140 mg every two weeks or 420 mg 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 percent more than placebo and 40.7 percent more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1 percent, 50.5 percent and 40.8 percent of patients on Repatha, ezetimibe and placebo, respectively.

Comment: Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option. In 2015, it was approved for dyslipidaemia in the US and EU.