Portola Pharmaceuticals Inc. is on the cusp of FDA action on its universal anticoagulant reversal agent AndexXa (andexanet alfa) with a user fee date of Aug. 17. But should it win that approval, it will have to wait until next year to gain bonus Medicare payments as an important new technology for hospital patients.
Both AndexXa and Boehringer Ingelheim GMBH's Praxbind (idarucizumab), a reversal agent specifically for Pradaxa (dabigatran), were under consideration for...