FDA Lifts Cloud Over J&J’s Xarelto With ROCKET-AF Re-Analysis
Agency reaffirms safety and efficacy in atrial fibrillation patients despite use of faulty coagulation monitoring device in pivotal trial led by current FDA Commissioner Robert Califf when he was at Duke University.
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A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.