Xarelto (rivaroxaban) is on the agenda of the FDA expert committee for possible recommendation for approval for use in heart attack and unstable angina. ACS is short for acute coronary syndromes and encompasses-UA or unstable angina, NSTEMI (Non ST Segment Elevation Myocardial Infarction) and STEMI (ST Segment Elevation Myocardial Infarction) which challenges millions of patients each year.
This editor was fortunate to see the data from a key study (at the American Heart Association meeting) which will be presented today which is known as ATLAS ACS 2 TIMI 51. The data are impressive in showing a balance of significant benefits versus risks which appear to be a crucial new approach to management of these heart patients.
The 219 page document is available at www.fda.gov and may lead to an important new tool for cardiologists and patients. This may save many lives.