BioCentury
ARTICLE | Company News

Breakthrough designation for Portola's andexanet alfa

November 26, 2013 1:20 AM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said FDA granted breakthrough therapy designation for andexanet alfa ( PRT4445) to reverse the anticoagulant activity of Factor Xa inhibitors. Next half, the company plans to start Phase III testing of the recombinant, modified Factor Xa molecule. Portola has a number of deals to evaluate the ability of andexanet alfa to reverse the anticoagulation activity of marketed Factor Xa inhibitors, including Xarelto rivaroxaban from Bayer AG (Xetra:BAYN) and partner Johnson & Johnson (NYSE:JNJ); Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and partner Pfizer Inc. (NYSE:PFE); and edoxaban from Daiichi Sankyo Co. Ltd. (Tokyo:4568). ...