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Amgen's Repatha gets nod for expanded European approval

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Amgen's Repatha gets nod for expanded European approval

Amgen Inc. said the European Commission expanded the approval of its cholesterol drug Repatha to prevent heart attack and stroke in adults with certain forms of cardiovascular disease.

Results of a late-stage clinical trial showed that the drug reduced risk of heart attack by 27%, the risk of stroke by 21% and risk of coronary revascularization by 22%.

The new indication is for adults with established atherosclerotic cardiovascular disease such as myocardial infarction, stroke or peripheral arterial disease and is meant to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol levels.

The company previously secured the same expanded approval by the U.S. Food and Drug Administration in December 2017.

Repatha global sales grew 151% to $123 million during the first quarter of 2018, up from $49 million in the prior-year period.