Portola Pharmaceuticals, Inc. Initiates Phase 3 Study Of Andexanet Alfa, Potential First-In-Class Factor Xa Inhibitor Reversal Agent, Under Accelerated Approval Pathway

Published: Mar 19, 2014

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SOUTH SAN FRANCISCO, Calif., March 19, 2014 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (Nasdaq:PTLA) today announced that it has initiated a Phase 3 study of andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent. The study will evaluate the safety and efficacy of andexanet alfa with Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc.'s (NYSE: PFE) Factor Xa inhibitor Eliquis® (apixaban). Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as a potential first-in-class antidote to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or who require emergency surgery. The Company is pursuing an Accelerated Approval pathway for andexanet alfa, which is the only agent that has demonstrated reversal of the anticoagulation activity of Factor Xa inhibitors as measured by biomarkers, including anti-Factor Xa activity, in human studies.

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