Posted by Michael Wonder on 02 Dec 2017
FDA approves Amgen's Repatha (evolocumab) to prevent heart attack and stroke
1 December 2017 - Following FDA priority review, Repatha is the only PCSK9 inhibitor approved to reduce risk of heart attack, stroke and coronary revascularisation.
Amgen today announced that following priority review of its supplemental Biologics License Application, the U.S. FDA approved Repatha (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularisations in adults with established cardiovascular disease.
In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularisation by 22%.
