![]() Currently, there are no approved Factor Xa inhibitor antidotes.ĪndexXa (andexanet alfa), an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. patients could benefit from an antidote annually. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 U.S. treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. ![]() In 2016, approximately 90,000 patients in the U.S. ![]() The BLA seeks initial approval of AndexXa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. Portola is developing AndexXa as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. The resubmission includes supplemental information primarily related to analytics and manufacturing, as requested by the FDA in a complete response letter issued to Portola last year. Food and Drug Administration (FDA) has found its resubmitted Biologics License Application (BLA) for AndexXa ® (andexanet alfa) to be acceptable for review, with an action due date of February 2, 2018. ® (Nasdaq:PTLA) today announced that the U.S. 15, 2017 (GLOBE NEWSWIRE) - Portola Pharmaceuticals Inc.
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