- The FDA and the EMA are both separately reviewing one of the main trials used to gain approval for Johnson & Johnson's anticoagulant Xarelto (rivoroxaban). Regulators are concerned the INRatio device used to test patients in the trial was defective and therefore could have produced skewed results.
- The trial in question was run by Dr. Robert Califf, current nominee for FDA Commissioner.
- Previously, in 2005 and 2006, the FDA sent warning letters to the manufacturer of the INRatio Device citing erroneous results. However, these concerns did not come up during the FDA's product review process in 2011.
There's a lot at stake here. Not only is Xarelto the top-selling anticoagulant in the new oral anticoagulant (NOAC) class, with $3.7 billion in sales, but Dr. Califf is still waiting for a Congressional confirmation.
Focusing on the clinical implications, the INRatio device was used during ROCKET-AF trials to test Xarelto against warfarin to assess warfarin's clotting. The point of the trial was to assess the clotting features of each product, with the goal of showing non-inferiority—an important finding considering warfarin had been the standard of care for more than 50 years.
Despite concerns about the accuracy of the INRatio device and Califf's career trajectory, the reality is Xarelto has been in wide usage for four years, allowing manufacturer Janssen to generate a lot of post-marketing data. For Dr. Califf, those in-the-know indicate he has broad bipartisan support. So there's a chance that this could prove to ultimately be a minor setback as he prepares for confirmation as FDA Commissioner.