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June 11, 2014
08:10 EDTPTLAPortola announces andexanet alfa, enoxaparin 'positive' Phase 2 data
Portola Pharmaceuticals announced that a Phase 2 proof-of-concept study in healthy volunteers demonstrated that andexanet alfa immediately reversed the anticoagulation activity of enoxaparin. Andexanet alfa was well tolerated with no serious adverse events reported. Detailed data will be presented during both oral and poster sessions at the 60th Scientific and Standardization Committee Meeting of the International Society on Thrombosis and Haemostasis. Portola is developing andexanet alfa to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are experiencing a major bleeding episode or who require emergency surgery. Andexanet alfa was well tolerated with no thrombotic events or serious adverse events reported. No antibodies to andexanet alfa, Factor Xa or Factor X were observed.
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March 2, 2015
08:15 EDTPTLAPortola announces full results from positive Phase 3 ANNEXA-R study
Portola Pharmaceuticals announced full results from the first part of the Phase 3 ANNEXA-R study, which is evaluating the safety and efficacy of andexanet alfa with the Factor Xa inhibitor XARELTO in healthy volunteers. Results showed the first part of this registration-enabling study met all primary and secondary endpoints with high statistical significance. Andexanet alfa administered as an intravenous bolus produced rapid and significant reversal of the anticoagulant effect of XARELTO as measured by anti-Factor Xa activity. Additionally, there was a significant reduction in the level of free XARELTO in the plasma, and thrombin generation was rapidly restored to within the normal baseline range following administration of andexanet alfa. In the study, andexanet alfa was well tolerated. There were no serious or severe adverse events, no thrombotic events, and no antibodies to Factor X or Xa observed. Andexanet alfa, a FDA-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity in patients treated with an oral or injectable Factor Xa inhibitor. Andexanet alfa has the potential to be a first-in-class antidote for anticoagulated patients who suffer a major bleeding episode or require emergency surgery. The randomized, double-blind, placebo-controlled Phase 3 ANNEXA-R study is evaluating the safety and efficacy of andexanet alfa in reversing XARELTO-induced anticoagulation in healthy volunteers ages 50-75 years. Efficacy is being evaluated using biomarker endpoints, with anti-Factor Xa levels as the primary endpoint. Secondary endpoints include plasma levels of free unbound XARELTO and endogenous thrombin potential, a measure of thrombin generation. In the first part of the ANNEXA-R study, 41 healthy volunteers were given XARELTO 20 mg once daily for four days to steady state. They were then randomized in a 2:1 ratio to receive at Cmax either andexanet alfa administered as an 800 mg IV bolus or placebo. Results showed that, for the primary endpoint, andexanet alfa reduced the anti-Factor Xa activity of rivaroxaban from baseline to nadir by >90 percent, a highly significant difference.
February 26, 2015
08:20 EDTPTLAPortola Pharmaceuticals receives FDA ODD for andexanet alfa
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