Portola Pharmaceuticals Announces Results Demonstrating Andexxa® was Associated with Lowest Rate of Mortality in Patients with Multiple Types of Factor Xa Inhibitor-Related Bleeds
SOUTH SAN FRANCISCO, Calif., March 16, 2020 /PRNewswire/ -- Portola Pharmaceuticals, Inc., Inc.® (Nasdaq: PTLA) today 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 number of patients experiencing serious, life-threatening bleeding associated with Factor Xa inhibitors continues to increase as their use grows rapidly in the U.S. and Europe," said Craig I. Coleman, Pharm.D., University of Connecticut, School of Pharmacy and Hartford Hospital Evidence-Based Practice Center. "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."
Key results, 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),* demonstrated:
"This important comparison of Andexxa to 4F-PCC demonstrated lower 30-day mortality with the use of Andexxa in patients with Factor Xa inhibitor-related bleeding across multiple types of bleeds," said Alexander T. Cohen, MBBS, M.Sc., M.D., a consultant physician and epidemiologist at Guy's and St Thomas' Hospitals NHS Foundation Trust. "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."
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.
"These findings contribute to the growing body of evidence supporting the potential life-saving benefits of Andexxa, the first and only FDA-approved reversal agent for the Factor Xa inhibitors rivaroxaban or apixaban," said Rajiv Patni, M.D., Portola's chief medical officer. "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 prioritize both the clinical value it provides and responsible budgeting in their patient care."
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.
Data accepted by ACC.20/WCC* includes:
*Note: The ACC.20/WCC meeting in Chicago has been cancelled due to public health concerns and will now be held virtually. Abstracts originally accepted for the meeting are available at: https://www.abstractsonline.com/pp8/#!/8992.
Important Safety Information
The most frequently reported adverse reactions in clinical trials in healthy subjects with Andexxa were mild or moderate infusion-related reactions comprising symptoms such as flushing and feeling hot (very common), and cough, dysgeusia, and dyspnea (common). Amongst bleeding patients, commonly reported side effects were ischemic stroke and pyrexia, with uncommon reported side effects of cerebral infarction, cerebrovascular accident, transient ischemic attack, acute myocardial infarction, cardiac arrest, myocardial infarction, deep vein thrombosis, iliac artery occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more information, including Boxed Warning, at www.Andexxa.com.
About Portola Pharmaceuticals, Inc.
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SOURCE Portola Pharmaceuticals, Inc.®
Company Codes: NASDAQ-NMS:PTLA