FDA Approval for evolocumab as secondary prevention in CVD patients
The U.S. Food and Drug Administration (FDA) approved evolocumab as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. In the evolocumab CV outcomes study (FOURIER), adding evolocumab to optimized statin therapy reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization by 22 percent.
“Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with evolocumab, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering." said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. 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 hyperlipidemia to reduce LDL-C.