Amgen announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1
“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 LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering,” Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said
In the Repatha cardiovascular outcomes study (FOURIER), Repatha 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.2
“We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine,” Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen, said.
The FDA also approved Repatha 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 low density lipoprotein cholesterol (LDL-C).1
1 Repatha® U.S. Prescribing Information. Amgen.
2 Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.