Posted by Michael Wonder on 17 Aug 2017
Portola Pharmaceuticals announces AndexXa (andexanet alfa) biologics license application resubmission accepted for review by U.S. FDA
15 August 2017 - Portola Pharmaceuticals today announced that the U.S. FDA has found its resubmitted biologics license application for AndexXa (andexanet alfa) to be acceptable for review, with an action due date of 2 February 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 anti-coagulated 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.
