Because of the lack of the antidote for apixaban and rivaroxaban, patient and doctors alike, have been reluctant to use these medications. An antidote has been anticipated for a long time.
The development of AndexXa has not been without problems. In August 2017 the FDA rejected AndexXa. Additional information primarily related to manufacturing was requested by the FDA. This led eventually to a manufacturing required changeover by the FDA.
AndexXa was granted accelerated approval by the FDA on May 3, 2018. However the manufacturer is required to conduct a postmarketing study (Study-18-513: “A Phase 4 randomized trial of ANDEXXA in acute intracranial hemorrhage in patients receiving oral factor Xa inhibitors”) to validate the data.
In addition it is expected that the initial supplies may be limited because of the aforementioned manufacturing changeover required by the FDA.
AndexXa is a, first in class, modified recombinant derivative of factor Xa. It acts as a decoy receptor with a higher affinity to the factor Xa inhibitor than natural factor Xa. It is manifactured by Portola Pharmaceuticals
Of note is that Praxbind (idarucizumab) is approved as an antidote for Pradaxa (dabigatran)