The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention.
The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI 51 trial. On the one hand, the sponsor (Johnson & Johnson) and the TIMI investigators (Jessica Mega, C. Michael Gibson, and Eugene Braunwald) portrayed a robustly positive trial that strongly demonstrated the beneficial effects of low dose rivaroxaban in ACS when added to dual antiplatelet therapy. On the other hand, one FDA reviewer, Medical Team Leader Tom Marciniak, raised multiple questions about the validity of the trial and its conclusions because of an alarming amount of early withdrawals and missing data. His view was largely endorsed by several committee members, including Steve Nissen and Sanjay Kaul.
In a press release, J&J said it “will ensure the questions raised today are addressed with the FDA.”
See my previous post for a detailed live account of the advisory committee meeting.