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|Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa™ (andexanet alfa)|
In the CRL for AndexXa, the
“Because AndexXa addresses an urgent unmet medical need, we and the
Conference Call Details
About the Need for a Factor Xa Inhibitor Antidote
Portola’s BLA for AndexXa was based on data from two Phase 3 ANNEXA™ studies that evaluated the safety and efficacy of AndexXa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in older healthy volunteers. Results of those studies were published online by
The BLA also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study. Portola is currently evaluating AndexXa in this global, Phase 3b/4 single-arm, open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed.