Portola Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has found its resubmitted Biologics License Application andexanet alfa (AndexXa) 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 andexanet alfa 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 Biologics License Application seeks initial approval of andexanet alfa 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.