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Medicines licensing

Concerns raised about trial supporting top selling anticoagulant drug

The validity of data produced by a pivotal trial to gain approval for direct oral anticoagulant rivaroxaban (Xarelto) from US and European regulators has been called into question by an investigation published by The BMJ.

The ROCKET-AF trial – published in the New England Journal of Medicine (NEJM) in 2011[1] – used a point of care device to measure international normalised (INR) ratio in patients taking warfarin, which The BMJ discovered had been recalled in December 2014 after giving falsely low test results, raising concerns about the accuracy of data on rivaroxaban’s safety profile. Rivaroxaban is manufactured by Bayer and is marketed in the US by Janssen, part of Johnson and Johnson.

The makers of the INRatio device told The BMJ that the device’s fault dated back to 2002. The US Food and Drug Administration (FDA) told The BMJ that it was “aware of concerns regarding the INRatio device and its use in the ROCKET-AF trial and is reviewing relevant data”. The European Medicines Agency (EMA) has also said it is investigating.

Harlan Krumholz, former FDA reviewer and professor of medicine at Yale University in Connecticut, said the NEJM should place an “immediate expression of concern” on the ROCKET-AF paper to notify the medical community, and that there should be “an investigation by an independent group of experts to quickly determine if there are grounds for retraction”.

However, attempts to access the original data have so far been thwarted. Bayer told The BMJ that it has only signed up to sharing information on “study reports for new medicines approved in the US and the EU after January 1, 2014”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200627

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  • The validity of data produced by a pivotal trial to gain approval for direct oral anticoagulant rivaroxaban (Xarelto) from US and European regulators has been called into question by an investigation published by The BMJ.

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