Last year, results from a key trial of Johnson & Johnson and Bayer’s Xarelto came into question, as investigators had used a later-recalled monitoring device. But now, the British Medical Journal says the companies knew about the device concerns while the trial was ongoing and did not notify trial monitors or regulators.
Janssen, J&J’s pharma branch, set up a safety recheck program in 2008 after investigators grew worried about accuracy and reliability with the INRatio device they were using to track blood clotting in trial participants, the BMJ reports.
But the company didn’t share the data generated by that recheck program with the trial’s safety monitoring board or with the FDA ahead of the Xarelto approval process, the journal says.
Janssen used the INRatio device to monitor patients in the warfarin arm of the Phase III ROCKET AF trial, a cornerstone of Xarelto's FDA approval filing. That trial compared Xarelto's performance with that of warfarin, the standard of care at the time.
J&J's partner Bayer, which markets Xarelto overseas, knew about the device concerns as the trial progressed, but it didn’t know about the recheck program until earlier this year, the BMJ notes. One Bayer official testified in a lawsuit that Janssen, which conducted and managed the trial, kept the program from the German drugmaker.
U.S. patients are suing both companies, claiming they misled users about Xarelto’s safety and efficacy.
Janssen and Bayer, though, each countered “the central premise of BMJ’s report” in separate statements to FiercePharma.
A Janssen spokeswoman pointed out that “the data in question represent fewer than one twentieth of 1% of the 366,000 measurements taken during the ROCKET AF trial and they could not have had any impact on the conclusions of the trial.”
Bayer added that the report includes “misleading statements which may unnecessarily alarm patients.”
J&J and Bayer will “continue to ensure that health authorities receive all required and accurate information regarding past and ongoing clinical trials,” the J&J spokeswoman noted.
The European Medicines Agency, for one, may agree with J&J. After launching a probe last December, the regulatory body announced in February that the device had not distorted the main findings of the study, which established Xarelto's superiority over warfarin as a treatment for atrial fibrillation.
"Xarelto can continue to be used as before, in line with the current prescribing information," the agency said on its website.
Xarelto has been a key product for both companies since it stormed out of the gate, and it currently leads a next-gen anticoagulant market that also comprises Boehringer Ingelheim’s Pradaxa, Pfizer and Bristol-Myers Squibb’s Eliquis and Daiichi Sankyo’s Savaysa. Just last week, new Bayer CEO Werner Baumann raised peak sales potential for the drug, taking the company estimate to more than €5 billion from €3.5 billion.
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