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In the study, andexanet alfa was well tolerated, with no serious adverse events, thrombotic events, or antibodies to Factor X or Xa reported . Jun 15: Portola Pharmaceuticals, Bristol-Myers Squibb Company and Pfizer jointly announced that andexanet alfa met all primary and secondary endpoints in a PIII study determining safety and efficacy.
Jul 14: CMC Biologics enters in to a commercial supply agreement with Portola Pharmaceuticals, for development of andexanet alfa for use in patients with a major bleed/who require emergency surgery . Jan 14: Portola Pharmaceuticals have indicated their intention to submit a Biologics License Application [BLA] at the end of 2015 for approval of andexanet alfa under an Accelerated Approval pathway . The company expects to launch the product in the US in 2016 . Aug 16: FDA issues a complete response letter asking Portola for additional information, primarily related to manufacturing.
Andexanet alfa receives orphan drug designation in US for reversing the anticoagulant effect of direct or indirect Factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery. Apr 15: Portola plans to submit data from the ANNEXA-A (apixaban) and ANNEXA-R (rivaroxaban) studies, and initial data from a Phase 4 study, as part of its Biologics License Application to the FDA under an Accelerated Approval pathway by the end of 2015 . The submission is supported by l data from phase III ANNEXA-A, ANNEXA-R and the phase IV ANNEXA-4.
Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, while retaining all rights to the programme . Feb 14: Portola Pharmaceuticals has entered into a second clinical collaboration agreement with Bayer and Janssen to evaluate andexanet alfa in PIII registration studies with rivaroxaban which are expected to start in H1 2014 . In the first part of the study, 32 subjects will be given apixaban 5mg twice daily and then randomized in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus or to placebo.
In the second part, 32 subjects will be randomized in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus followed by a continuous infusion of 480mg at 4mg/min for 120 minutes or to placebo.
Once administration is stopped, andexanet alfa is rapidly cleared and anticoagulant therapy can be re-started.