Portola Pharmaceuticals, Inc. Initiates Phase 2 Study Of Andexanet Alfa, Potential First-In-Class Factor Xa Inhibitor Reversal Agent, And Factor Xa Inhibitor Edoxaban
Published: Mar 27, 2014
SOUTH SAN FRANCISCO, Calif., March 27, 2014 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (Nasdaq:PTLA) today announced that it has initiated a Phase 2 proof-of-concept study to evaluate andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent, as a reversal agent for Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban in healthy volunteers. 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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