Approval of evolocumab by the European Commission (EC) is now in place for patients with established atherosclerotic CVD (myocardial infarction [MI], stroke, or peripheral arterial disease) to reduce CV risk. Evolocumab is a human monoclonal antibody that inhibits PCSK9 and results in the lowering of LDL-c levels.

This is based on the findings from the FOURIER trial, including 27564 patients, that showed that evolocumab op top of maximally tolerated statin therapy resulted in a 27% risk reduction of MI, 21% risk reduction of stroke and 22% risk reduction of coronary revascularization compared to patients treated with placebo and statins over a mean follow-up of 26 months.

"We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With far too many patients at risk of recurrent cardiovascular events, we are pleased that the European Commission has approved evolumab to prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease.”

Source: Press release Amgen, May 16, 2018