December 29th, 2011
J&J Applies for ACS Indication for Rivaroxaban (Xarelto)
Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients.
Following a succession of failed trials, ATLAS was the first trial to show a benefit in ACS with an anticoagulant. One key difference highlighted by many experts was the low dose of rivaroxaban used in the trial. In remarks published on CardioExchange, Samuel Goldhaber said that the trial “changes forever the way we’ll think about the pathophysiology of ACS and the way we’ll manage patients with STEMI, NSTEMI, or unstable angina.”
Link to press release