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
Phase of Trial: Phase III
Latest Information Update: 22 Dec 2017
At a glance
- Drugs Andexanet alfa (Primary)
- Indications Haemorrhage
- Focus Registrational; Therapeutic Use
- Acronyms ANNEXA-R
- Sponsors Portola Pharmaceuticals
- 22 Dec 2017 According to a Portola Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (BLA) for AndexXa (andexanet alfa) by 90 days. The company recently submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process. The FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History