Andexxa Phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care
AstraZeneca to proceed with regulatory filings to convert from conditional to full approval in the US and EU.ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of Andexxa (andexanet alfa) in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial haemorrhage, will be stopped early.[1] The decision is based on achieving pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.[1,2] The recommendation