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: 23 May 2018
At a glance
- Drugs Andexanet alfa (Primary)
- Indications Haemorrhage
- Focus Registrational; Therapeutic Use
- Acronyms ANNEXA-4
- Sponsors Portola Pharmaceuticals
- 03 May 2018 According to a Portola Pharmaceuticals media release, based on the results of ANNEXA-R, ANNEXA-A and interim data from ANNEXA-4 (n=185), the U.S. Food and Drug Administration (FDA) has approved Andexxa, the first and only antidote for patients treated with rivaroxaban and apixaban, in reversing the anticoagulant activity of the Factor Xa inhibitors.
- 03 May 2018 Based on the results of ANNEXA-R, ANNEXA-A and interim data from ANNEXA-4, the Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for andexanet alfa is under review. The Committee for Medicinal Products for Human Use (CHMP) communicated a positive trend vote on the MAA in February 2018. A formal opinion from the CHMP is expected by the end of 2018, and the European Commission is expected to issue a decision in early 2019.
- 12 Mar 2018 Interim results (n=228) presented at the American College of Cardiology's 67th Annual Scientific Session Expo 2018, according to a Portola Pharmaceuticals media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History