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