FDA Advisory Committee rejects Xarelto for Acute Coronary Syndrome

The Cardiovascular and Renal Drugs Advisory Committee voted 6-4 (with one abstention) against the approval of Xarelto (rivaroxaban) 2.5 mg BID from Johnson & Johnson/Bayer HealthCare, in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome). The FDA is not bound to follow the panel's advice, although it usually does, and a final decision is expected by June 29