The FDA has found the resubmitted Biologics License Application (BLA) from Portola Pharmaceuticals Inc. relating to AndexXa (andexanet alfa) to be acceptable for review.

Portola Pharmaceuticals Inc. announced that the 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.

Comment: In 2016, approximately 90,000 patients in the U.S. 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 U.S. patients could benefit from an antidote annually. Currently, there are no approved Factor Xa inhibitor antidotes.