Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

Trial Profile

Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

Recruiting
Phase of Trial: Phase III/IV

Latest Information Update: 15 Aug 2017

At a glance

  • Drugs Andexanet alfa (Primary)
  • Indications Haemorrhage
  • Focus Registrational; Therapeutic Use
  • Acronyms ANNEXA-4
  • Sponsors Portola Pharmaceuticals
  • Most Recent Events

    • 15 Aug 2017 According to a Portola Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has found its resubmitted Biologics License Application (BLA) for AndexXa (andexanet alfa) to be acceptable for review, with an action due date of February 2, 2018.
    • 03 Aug 2017 According to a Portola Pharmaceuticals media release, the company resubmitted a Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA for of AndexXa (andexanet alfa). The resubmission includes supplemental information primarily related to manufacturing, as requested by the FDA in a complete response letter (CRL) issued to Portola in August 2016.
    • 28 Apr 2017 Interim results assessing the efficacy and safety, presented at the 69th Annual Meeting of the American Academy of Neurology.
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