Posted by Michael Wonder on 24 Mar 2018
Amgen receives positive CHMP opinion recognising that Repatha (evolocumab) prevents heart attacks and strokes
23 March 2018 - Amgen continues to work closely with payers on a country-by-country basis to ensure access to Repatha for high-risk cardiovascular patients.
Amgen today announced that the CHMP of the 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 recognises 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 revascularisations on top of maximally tolerated statin therapy.
