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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

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

    • 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.
    • 19 Aug 2016 According to a Portola Pharmaceuticals media release, based on data from this and other study (see profile 242840) Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA), completed the validation period, and has been accepted for review. The MAA also included limited adjudicated efficacy and safety data from initial patients of ANNEXA-4 study.
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