CHMP recommends approval of Repatha for established atherosclerotic cardiovascular disease.- Amgen.

Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion to include a new indication in the Repatha (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. The recommended label recognizes the positive findings from the Repatha cardiovascular outcomes study (FOURIER) and includes data on the additional reduction and prevention of heart attacks, strokes and coronary revascularizations on top of maximally tolerated statin therapy.

The Repatha cardiovascular outcomes study 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.

Comment: On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved a new indication for Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease following a priority review of Amgen's supplemental Biologics License Application.