A resubmitted Biologics License Application (BLA) from California-based Portola Pharmaceuticals was recently deemed acceptable for review by the U.S. Food and Drug Administration and assigned an expected action due date of Feb. 2, 2018.
To be reconsidered, the BLA was amended with supplementary information with more detail on analytics and manufacturing at the FDA’s request in 2016.
Portola has been developing its AndexXa (andexanet alfa) as an investigational anticoagulant treatment with the potential to normalize hemostatic processes in human blood. Potentially it can act as a reversal agent for patients encountering critical uncontrolled and/or life-threatening bleeding incidents or needing emergency surgical care.
AndexXa, the first compounded product indicated for targeting specific coagulation issues, is “a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor,” company representatives said.
Headquartered in South San Francisco, Portola Pharmaceuticals Inc. develops and markets therapies for thrombosis and other hematologic conditions. Its first product, Bevyxxa (betrixaban), obtained FDA approval in June. Portola is also advancing two clinical trials: one for AndexXa and a second for cerdulatinib, for treating hematologic cancers.