Portola Pharmaceuticals Announces BLA Resubmission Accepted for Review
Portola Pharmaceuticals Inc. recently announced the US 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. 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.
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 BLA seeks initial approval of AndexXa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
In 2016, approximately 90,000 patients in the US treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. Including patients taking the injectable Factor Xa inhibitor enoxaparin, it is estimated that more than 150,000 US patients could benefit from an antidote annually. Currently, there are no approved Factor Xa inhibitor antidotes.
AndexXa (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. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity, the anticoagulant mechanism of these agents.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The company’s first medicine, Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the US FDA in June 2017. The company is also working to advance two clinical programs for AndexXa (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. For more information, visit http://www.portola.com.
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