LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) on Monday said the Phase 4 study of Andexxa in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial haemorrhage, will be stopped early after meeting its efficacy endpoint.
The Data and Safety Monitoring Board (DSMB) has recommended to stop the study after an interim assessment of 450 patients showed achievement of pre-specified criteria on haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.
The treatment has been granted accelerated approval in the US and is conditionally approved in the EU, Switzerland and UK for adults treated with FXa inhibitors apixaban and rivaroxaban.
The company plans for regulatory filings in the US and EU to convert to full label approval.
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