Portola Pharmaceuticals, Inc. announced new data reinforcing the value of Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only FDA-approved reversal agent for the Factor Xa inhibitors rivaroxaban or apixaban. The data demonstrated that Andexxa was associated with a lower rate of in-hospital and 30-day mortality in patients with life-threatening Factor Xa inhibitor-related bleeds compared with other treatment options. This included lower mortality across multiple bleed types including intracranial hemorrhage (ICH), gastrointestinal bleeding (GI) and bleeding due to trauma, when compared to 4-factor prothrombin complex concentrate (4F-PCC) therapy, which is approved only for the reversal of warfarin. The new findings are based on the results of multiple data sets. One analysis provided an indirect comparison of Andexxa and 4F-PCC using case-matched data from two large studies of Factor Xa inhibitor patients – the 322-patient ANNEXA-4 study and ORANGE, a three-year prospective registry of patients admitted to UK hospitals with major bleeding who received 4F-PCC. The second was a real-world study of electronic medical records from 45 U.S. hospitals used to identify patients admitted for bleeding related to Factor Xa inhibitors (1,075 bleeds) and managed with either Andexxa or 4F-PCC. In addition, new health economics and outcomes research (HEOR) data reveal the burden of bleeding requiring hospitalization on patients and healthcare systems. Hospitalization for ICH bleeds was associated with the highest in-patient mortality, the greatest need for further out-of-home care and the longest length of stay in the hospital compared to other bleed types (abstract #1320-233 /233). The high thrombotic risk profile (e.g., those with atrial fibrillation [AF] or deep vein thrombosis/pulmonary embolism [DVT/PE]) of included patients suggests that many could have been receiving oral anticoagulants.