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FDA panel rebuffs J&J's Xarelto for ACS

January 17, 2014 1:19 AM UTC

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10-0, with one abstention, against approval of Xarelto rivaroxaban from Johnson & Johnson (NYSE:JNJ) to reduce the risk of thrombotic cardiovascular events in patients after suffering acute coronary syndrome (ACS). J&J is seeking to expand Xarelto's label to include the drug's use for 90 days for the indication. A decision on the sNDA is expected in mid-February, though J&J is not disclosing a specific PDUFA date. FDA has twice rejected Xarelto for the indication because of inadequate data. ...