The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise when it first came out, the pivotal ATLAS ACS 2-TIMI 51 trial has been bedeviled by criticism since the FDA drew attention to the unusually large amount of missing trial data.
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