By Marie Rosenthal
The FDA granted a new indication for evolocumab (Repatha, Amgen) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease (CVD).
The FDA also approved evolocumab to be used as an adjunct to diet, alone or with other lipid-lowering therapies, such as statins, for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
Evolocumab is a human