Countering Xarelto critics, FDA backs clot buster's benefits despite study's faulty device

FDA sign

Johnson & Johnson and Bayer can breathe easy: The FDA declared Wednesday that a faulty device didn't distort the results of a key Xarelto trial.

In the wake of questions about Xarelto's crucial atrial fibrillation trial, the agency said it’s “quite likely” that the later-recalled monitoring device prompted higher-than-usual doses of the old-guard therapy warfarin in the trial. That's the treatment Xarelto topped in the Phase III study, ROCKET AF. 

But the increased doses “were likely to have [a] quite modest” effect on clinical results, the agency said. It's “very unlikely” that, if the device had been up to snuff, Xarelto’s risk/benefit profile--compared with warfarin’s--would have come out looking much different, the regulators wrote.


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The FDA isn’t the first regulatory agency to come to that conclusion. After launching its own probe last December, the European Medicines Agency in February said the now-recalled Alere device hadn’t distorted ROCKET’s main findings, which established Xarelto’s superiority over warfarin.

Meanwhile, it’s great news for the two companies, both of which count on big sales from the standout med. Bayer, for one, recently hiked peak sales estimates for the drug, taking the company's forecast to more than €5 billion from €3.5 billion.

But they’re not totally in the clear. In September, an investigation by the BMJ faulted the pair for knowing about device-related concerns while the trial was ongoing--and failing to notify trial monitors or regulators about it.

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