A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha

Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Andexanet alfa (Primary)
  • Indications Haemorrhage
  • Focus Registrational; Therapeutic Use
  • Acronyms ANNEXA-R
  • 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) of 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.
    • 13 Oct 2016 According to a Portola Pharmaceuticals media release, the company expects to resubmit a Biologics License Application (BLA), AndexXa in 2017.
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