- A recombinant protein specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors
- Being developed as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergent surgery
- Designated a Breakthrough Therapy by the U.S. Food and Drug Administration
- We filed a Biologics License Application, or BLA, to the FDA in the first quarter of 2016. The BLA is subject to review under an Accelerated Approval pathway with a Prescription Drug User Fee Act, or PDUFA, date of August 17, 2016. The PDUFA date is the goal date for the FDA to complete its review of the BLA.
- Portola has commercial rights to andexanet alfa outside of Japan
- Currently being studied in ANNEXA-4, a Phase 3b/4 single-arm, open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin (a low molecular weight heparin and indirect Factor Xa inhibitor) who present with an acute major bleed.