AstraZeneca’s phase 4 trial stopped early after reaching pre-specified criteria

Betsy Goodfellow | June 5, 2023 | News story | Research and Development ANNEXA-I, Andexxa, AstraZeneca, Neurology, clinical trial 

AstraZeneca has announced that its post-marketing phase 4 ANNEXA-I trial has been stopped early after reaching its pre-specified stopping criteria. The trial was intended to assess the safety and efficacy of Andexxa (andexanet alfa) in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial haemorrhage.

The decision to stop the trial after it met its pre-specified stopping criteria of superior haemostatic efficacy was based on the drug limiting the expansion of a potentially life-threatening bleed in the brain compared to standard-of-care.

Stuart J Connolly, MD, FRCPC, senior scientist at Population Health Research Institute and professor emeritus at McMaster University in Ontario, Canada, commented: “We are pleased that the study has met its efficacy endpoint at the planned interim analysis, showing improved control of bleeding with targeted anticoagulation reversal, compared to usual care. We look forward to sharing the full efficacy and safety results after further analysis, with the hope that the data will pave the way for further guidance on the treatment of potentially life-threatening bleeds.”

Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, added: “Millions of people worldwide depend on FXa inhibitors to prevent harmful blood clots from forming, but these agents also carry a small but significant risk of increasing the likelihood that an acute major bleed could occur. We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required.”

AstraZeneca now plans to initiate closure of ANNEXA-I while proceeding with regulatory filings in the US and EU converting its approval to a full label approval.

Betsy Goodfellow

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