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TMI from TIMI: Xarelto and the Trouble with Very Large Trials

 
• By Cole Werble

With bigger clinical trials come potentially bigger problems. That, at least, is what sponsors of 15,000-plus trials in cardiovascular medicine are finding out. J&J/Bayer’s experience in late May with Xarelto for acute coronary syndrome is a case in point—and it also provides timely context for the surprising setback for another CV project, Pfizer/BMS' Eliquis.

There were two direct, explicit messages to NDA sponsors from the May 23 meeting of the Food & Drug Administration’s Cardio-Renal Drugs Advisory Committee review of Johnson & Johnson/Bayer AG’s Xarelto for a new indication.

The first came from the dean of FDA’s review process, Center for Drug Evaluation & Research Deputy Director Robert Temple. His worry: that as Phase III trials get larger and...

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