Portola Pharmaceuticals and the CHMP’s Oral Explanations for Andexanet Alfa and Betrixaban
Portola (PTLA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorization Application (MAA) for Portola’s factor Xa inhibitor antidote andexanet alfa. The agency has also communicated a negative trend vote for betrixaban, the firm’s oral, Factor Xa inhibitor.
Andexanet Alfa
Bill Lis, the chief executive officer of Portola said, “We are . . .