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.