AstraZeneca: Andexxa Phase IV trial stopped early
(CercleFinance.com) - AstraZeneca announces that Annexa-I, a post-marketing phase IV trial designed to evaluate the efficacy and safety of Andexxa, will be stopped prematurely.
The decision is based on meeting pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a life-threatening cerebral haemorrhage, compared to usual care.
The recommendation to stop the trial was made by the independent Data and Safety Monitoring Board following a planned interim efficacy evaluation which demonstrated the benefits of reversing Andexxa earlier in study recruitment than originally planned.
AstraZeneca will now initiate the closure of the ANNEXA-I study and proceed with regulatory filings in the US and EU to obtain full label approval. Full efficacy and safety results will be submitted for presentation at a future medical meeting and for publication.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
The decision is based on meeting pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a life-threatening cerebral haemorrhage, compared to usual care.
The recommendation to stop the trial was made by the independent Data and Safety Monitoring Board following a planned interim efficacy evaluation which demonstrated the benefits of reversing Andexxa earlier in study recruitment than originally planned.
AstraZeneca will now initiate the closure of the ANNEXA-I study and proceed with regulatory filings in the US and EU to obtain full label approval. Full efficacy and safety results will be submitted for presentation at a future medical meeting and for publication.
Copyright (c) 2023 CercleFinance.com. All rights reserved.