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Amgen Receives European Commission Approval For Repatha

Amgen (AMGN) said Wednesday that the European Commission approved a new indication in the Repatha or evolocumab label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol or LDL-C levels.

With the expanded label now in place, Amgen said it is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

Of all the modifiable risk factors for heart attack and stroke, lowering high LDL-C is one of the most important and impactful. Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Repatha is a groundbreaking medicine proven to significantly lower "bad cholesterol" or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.

The approval by the EC recognizes the positive findings from the Repatha cardiovascular outcomes study (FOURIER), expanding the label to include data on the additional reduction and prevention of heart attacks, strokes and coronary revascularizations on top of maximally tolerated statin therapy.

FOURIER showed reductions in the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization procedures by 22 percent in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.

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