The US FDA has approved evolocumab (Repatha, Amgen) for the prevention of myocardial infarction, strokes and coronary revascularisations in adults with established cardiovascular disease. The approval means that the drug is now the first PCSK9 inhibitor to have such an indication in the USA.
A press release reports that the FOURIER study showed that evolocumab reduced the risk of myocardial infarction by 27%, the risk of stroke by 21% and the risk of coronary revascularisation by 22%. Overall, the study found a statistically significant 15% reduction (p<0.001) in the risk of the primary composite endpoint, which included hospitalisation for unstable angina, coronary revascularisation, myocardial infarction, stroke or cardiovascular death.
Sean E Harper, executive vice president of Research and Development at Amgen, comments: “We are pleased that the FDA made the inclusion of our outcomes data a priority so that patients can benefit from Repatha’’s ability to reduce life-changing events of heart attacks and strokes. Despite treatment with current best therapy, many patients are still at high risk for cardiovascular events. Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering low-density lipoprotein (LDL) cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering.”
The FDA also approved evolocumab to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, for the treatment of adults with primary hyperlipidaemia to reduce LDL cholesterol.