AstraZeneca to seek full Andexxa approvals based on Phase IV data

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 hemorrhage, is to be stopped early.

The decision is based on achieving pre-specified stopping criteria of superior hemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care.

"The first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve hemostasis"This recommendation to stop the trial was made by the independent Data and Safety Monitoring Board (DSMB) following a planned interim assessment of efficacy after 450 patients had been randomized and followed for one month, which showed Andexxa’s reversal benefits earlier in the study enrolment than originally anticipated.