The European Commission (EC) has authorised a new indication in the evolocumab (Repatha, Amgen) label for adults with established atherosclerotic cardiovascular disease—myocardial infarction, stroke or peripheral arterial disease—to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol levels an adjunct to correction of other risk factors.
Evolocumab is a medicine proven to lower LDL cholesterol for high-risk patients who suffer from a combination of high LDL cholesterol and cardiovascular disease, and who continue to struggle with lowering their LDL cholesterol levels despite statin therapy. According to a press release, the recent authorisation by the EC recognises the positive findings from the evolocumab cardiovascular outcomes study (FOURIER), updating the label to include data on the additional effect of evolocumab on heart attacks, strokes and coronary revascularisations on top of the maximum-tolerated statin therapy.
Anthony C Hooper, executive vice president of Global Commercial Operations at Amgen, says: “With its ability to help prevent heart attacks and strokes, evolocumab offers hope for one of the greatest health challenges we face today. However, the majority of patients in Europe who could benefit from treatment with a PCSK9 inhibitor remain unserved and at risk of a cardiovascular event.”
Sean E Harper, executive vice president of Research and Development at Amgen, notes: “We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year. With far too many patients at risk of recurrent cardiovascular events, we are pleased that the EC has authorised evolocumab to help prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease. The science clearly indicates that ‘lower LDL-cholesterol is better’ and this decision underscores the role for evolocumab among high-risk patients for whom statins alone are not enough.”