Phase IV trial with reversal agent for FXa inhibitors stopped early due to superior hemostatic efficacyNews - June 13, 2023
The phase IV ANNEXA-I trial evaluating the efficacy and safety of andexanet alfa in patients on oral FXa inhibitors, including apixaban and rivaroxaban, experiencing an intracranial hemorrhage, will be stopped early due to overwhelming efficacy. This decision was made following a recommendation by an independent Data and Safety Monitoring Board, which based their recommendation on the results of a planned interim assessment of 450 patients who were followed for one month.
Andaxanet alfa is a reversal agent for the anticoagulation effects of direct oral FXa inhibitors. Reversal of anticoagulation is needed in patients experiencing life-threatening or uncontrolled bleeding. In ANNEXA-1, andaxanet alfa had superior ability to limit the expansion of a potentially life-threating bleed in the brain compared with usual care.
ANNEXA-I was a post-marketing, randomized, multi-center clinical trial that assessed the efficacy and safety of andaxanet alfa vs. usual care in 450 adult patients who experienced an acute intracranial hemorrhage and who have received oral FXa inhibitors, including apixaban and rivaroxaban. The primary endpoint was the rate of effective hemostasis, or stopping blood flow, following treatment with andexanet alfa compared with usual care.
Procedures of regulatory filings in the US and EU from conditional to full label approval will be initiated. The results of ANNEXA-I will be presented at a forthcoming medical meeting.