AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca 
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  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Review, Journal:  An Update on the "Novel" and Direct Oral Anticoagulants, and Long-Term Anticoagulant Therapy. (Pubmed Central) -  May 8, 2019   
    Concerns about bleeding risks of DOACs persist despite reassuring data in the literature and the development of specific antidotes. In this article, the authors present an overview of the basic pharmacology of DOACs and discuss their use in acute VTE, secondary VTE prevention, and specialized VTE patient populations and discuss therapeutic monitoring and reversal in the event of major bleeding.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Journal:  Andexanet Alfa for Reversing Factor Xa Inhibition. (Pubmed Central) -  May 2, 2019   
    Since the duration of the DOACs is much less than that of warfarin, it is unclear how many patients would actually need andexanet in clinical practice, since cessation of the DOAC may be all that is needed to effectively manage bleeding. Nonetheless, having andexanet available in cases of DOAC-associated severe or life-threatening bleeding represents a therapeutic advance and should provide an added level of comfort with the clinical use of DOACs.
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma, Pradaxa (dabigatran etexilate) / Boehringer Ingelheim
    Journal:  Bleeding Management under Direct Oral Anticoagulants (DOAC) (Pubmed Central) -  Apr 30, 2019   
    PCC in addition to unspecific measures, is indicated, as the direct antagonist andexanet alpha has not been approved in the EU. In contrast, the specific antagonist idarucizumab for acute dabigatran reversal is available in Germany.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Journal:  Andexanet alfa for the treatment of hemorrhage. (Pubmed Central) -  Apr 28, 2019   
    Expert Commentary: While initial reports on restoration of hemostasis and safety are promising, further study of andexanet is required to gauge its efficacy and toxicity, including a potential prothrombotic effect. Further, its use in patients requiring urgent surgery should be studied.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Journal:  Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. (Pubmed Central) -  Apr 20, 2019   
    P3
    In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327 .).
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Review, Journal:  Novel reversal agents and laboratory evaluation for direct-acting oral anticoagulants (DOAC): An update. (Pubmed Central) -  Apr 18, 2019   
    The available United States Food and Drug Administration (FDA) approved reversal agents, idarucizumab for dabigatrin and andexanet alfa for anti-Xa direct acting oral anticoagulants have given promising results but are prohibitively priced. Medline, Embase, and Scopus databases were thoroughly searched for clinical trials on laboratory investigations and specific as well as non-specific reversal-agents for DOACs.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, Portola Pharma
    Journal:  Comparison of reversal activity and mechanism of action of UHRA, andexanet, and PER977 on heparin and oral FXa inhibitors. (Pubmed Central) -  Apr 7, 2019   
    Anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparins (LMWHs), fondaparinux, and direct oral anticoagulants (DOACs) targeting thrombin (IIa) or factor Xa (FXa) are widely used in prevention and treatment of thromboembolic disorders...ITC confirmed binding of UHRA to all heparins, and binding of andexanet to edoxaban and rivaroxaban, and to the antithrombin-enoxaparin complex...Standard metrics of clot structure were found to correlate weakly with PER977's activity. This is the first study comparing 3 antidotes in development, with each exerting activity through a distinct mechanism.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, Bevyxxa (betrixaban) / AstraZeneca
    Trial completion date, Trial suspension, Trial primary completion date:  A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing (clinicaltrials.gov) -  Jan 30, 2019   
    P2,  N=36, Suspended, 
    Not yet recruiting --> Recruiting Trial completion date: Sep 2018 --> Dec 2019 | Recruiting --> Suspended | Trial primary completion date: Sep 2018 --> Dec 2019
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, Bevyxxa (betrixaban) / AstraZeneca
    Trial completion date, Trial primary completion date:  A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing (clinicaltrials.gov) -  Jun 7, 2018   
    P2,  N=36, Recruiting, 
    N=54 --> 157 Trial completion date: May 2018 --> Sep 2018 | Trial primary completion date: May 2018 --> Sep 2018
  • ||||||||||  Journal:  Reversal agents for oral antiplatelet and anticoagulant treatment during bleeding events: current strategies. (Pubmed Central) -  Apr 8, 2018   
    For patients presenting with severe bleeding while on dabigatran, we recommend discontinuation of dabigatran and intravenous administration of 5g idarucizumab...Until andexanet alpha becomes available we recommend discontinuation of the factor Xa inhibitor and administration of 50 units/kg 4-factor PCC. The decision to discontinue and/or reverse antithrombotic therapy should be made on a case-by-case basis and the competing risk from discontinuation and/or reversal of antithrombotic therapy should be taken in consideration.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, Bevyxxa (betrixaban) / AstraZeneca
    Enrollment open:  A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing (clinicaltrials.gov) -  Nov 7, 2017   
    P2,  N=36, Recruiting, 
    The decision to discontinue and/or reverse antithrombotic therapy should be made on a case-by-case basis and the competing risk from discontinuation and/or reversal of antithrombotic therapy should be taken in consideration. Suspended --> Recruiting
  • ||||||||||  Review, Journal:  Management of bleeding in patients receiving non-vitamin K antagonists. (Pubmed Central) -  Oct 22, 2017   
    Andexanet alfa reduces increased anti-factor Xa activity seen with the use of rivaroxaban and apixaban...The development of reversal agents is a major advancement in managing bleeding in the era of NOACs. Future studies will be required to determine the impact on important clinical outcomes.