Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)
Phase of Trial: Phase III/IV
Latest Information Update: 12 Dec 2017
At a glance
- Drugs Andexanet alfa (Primary)
- Indications Haemorrhage
- Focus Registrational; Therapeutic Use
- Acronyms ANNEXA-4
- Sponsors Portola Pharmaceuticals
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History