FDA Approves Evolocumab to Prevent Heart Attack and Stroke

On December 1, the FDA approved evolocumab (Repatha, Amgen) for the prevention of heart attack, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD), as well as for the treatment of adults with primary hyperlipidemia to decrease LDL-C. This is in addition to the original approval for people with Heterozygous and Homozygous FH. The approval was based on results of the outcomes trial known as FOURIER, which showed that not only does the PCSK9 inhibitor, evolocumab, lower LDL cholesterol, but it reduces the risk for cardiovascular events.

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