Portola Pharmaceuticals announced new data that they say reinforces the value of Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo). The company statement outlines that the data demonstrate 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 haemorrhage (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.
Andexxa is the first and only FDA-approved reversal agent for the Factor Xa inhibitors rivaroxaban or apixaban, indicated when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Craig I Coleman (University of Connecticut, School of Pharmacy and Hartford Hospital Evidence-Based Practice Center, Connecticut, USA) says in the press release: “For the first time, we are presenting real-world data that demonstrates that for these patients Andexxa was associated with the lowest in-hospital mortality across a variety of other treatment options.”
The results were originally scheduled to be presented at the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC), which has now been cancelled. They demonstrated:
- Case matched data showed 30-day mortality was 14.6% with Andexxa versus 34.1% with 4F-PCC across all bleed types, a relative risk reduction of 57.2%
- A separate analysis of real-world data showed in-hospital mortality was 4% with Andexxa and 10% with 4F-PCC across all bleed types (abstract #1055-05).
Alexander T Cohen, (Guy’s and St Thomas’ Hospitals NHS Foundation Trust, London, UK) says: “I believe these findings strengthen the case for the use of Andexxa versus 4F-PCC in these patients, and further establish Andexxa as the standard of care for a broad group of patients on rivaroxaban or apixaban who are experiencing life-threatening or uncontrolled bleeding.”
Portola’s chief medical officer Rajiv Patni states in the press release: “These findings contribute to the growing body of evidence supporting the potential life-saving benefits of Andexxa. We have a robust strategy to generate and present additional data over the next year, which we believe will enhance our ability to educate key hospital stakeholders that by choosing Andexxa, they can prioritise both the clinical value it provides and responsible budgeting in their patient care.”
In addition, according to the company statement, new health economics and outcomes research data reveal the burden of bleeding requiring hospitalisation on patients and healthcare systems. Hospitalisation 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. The high thrombotic risk profile (for example, those with atrial fibrillation or deep vein thrombosis/pulmonary embolism of included patients suggests that many could have been receiving oral anticoagulants.