ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.