FDA accepts Portola’s resubmitted BLA for Factor Xa antidote

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said FDA accepted for review a resubmitted BLA for AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) to reverse the anticoagulant activity of Factor Xa inhibitors. Its PDUFA date is Feb. 2, 2018.

The company is seeking AndexXa's approval to reverse the anticoagulant activity of Factor Xa inhibitors Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and Xarelto rivaroxaban from Bayer AG (Xetra:BAYN) in patients experiencing uncontrolled or life-threatening bleeding...