Antidote Drug For Newer Anticoagulants Is Denied FDA Approval

In mid-August 2016 the US FDA rejected Portola Pharmaceutical’s application to market AndexXa (andexanet alfa) as an antidote to these three direct Factor Xa inhibitors. (Eliquis, Xarelto, and Savaysa)

AndexXa is being developed for patients being treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Factor Xa plays a key role in blood coagulation.

The FDA also sought additional information related to manufacturing of the drug.

What does this mean?  Well, it is unfortunate, as many patients are now treated with these newer anticoagulants. It means that they continue to take them at their own risk.  For warfarin patients, it means nothing has changed.  Be fortunate that IF you experience any bleeding, warfarin has a reversal agent, Vitamin K, that can help tremendously.

At the present time it is unknown when Portola will be in a position to resubmit its AndexXa application to the FDA, much less when the FDA will make its next determination about AndexXa being approved, or not.

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