Andexanet alfa postmarketing trial stopped early due to superior efficacy
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Key takeaways:
- AstraZeneca announced a postmarketing trial assessing safety and efficacy of andexanet alfa stopped early due to superior efficacy.
- Andexanet alfa successfully reverses factor Xa inhibitor effects.
AstraZeneca announced the ANNEXA phase IV trial assessing the safety and efficacy of andexanet alfa stopped early after achieving prespecified criteria on hemostatic efficacy vs. usual care, according to a press release.
Andexanet alfa (Andexxa) is approved for patients prescribed oral factor Xa inhibitor treatment, including apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto, Janssen/Bayer), who are experiencing an intracranial hemorrhage. The decision was based on achieving prespecified stopping criteria of superior hemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, compared with usual care, according to the release.
The independent Data and Safety Monitoring Board made the recommendation to stop the trial after a planned interim assessment of efficacy, which came after 450 patients underwent randomization and were followed for 1 month. That data showed andexanet alfa’s reversal benefits earlier in the study enrolment than originally anticipated, according to the release.
“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,” Stuart J. Connolly, MD, FRCPC, senior scientist at the Population Health Research Institute and professor emeritus at McMaster University in Hamilton, Ontario, Canada, said in the release. “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.”
As Healio previously reported, data from the ANNEXA-4 trial demonstrated that andexanet alfa rapidly reversed the anticoagulation effects of factor Xa inhibitors in most patients with acute major bleeding caused by a factor Xa inhibitor, and enabled most patients to achieve good to excellent hemostasis.
Andexanet alfa is specifically designed to rapidly reverse the anticoagulation effects of direct oral factor Xa inhibitors due to life-threatening or uncontrolled bleeding. The treatment has been granted accelerated approval in the U.S. and is conditionally approved in the EU, Switzerland and U.K. (as Ondexxya) for adults treated with the factor Xa inhibitors apixaban and rivaroxaban. It is also approved in Japan (as Ondexxya) for the factor Xa inhibitors apixaban, rivaroxaban or edoxaban (Savaysa, Daiichi Sankyo).
In the release, AstraZeneca stated it will initiate closure of the ANNEXA-I trial and proceed with regulatory filings in the U.S. and EU to convert to full label approval, and that the full efficacy and safety results will be submitted for presentation at a forthcoming medical meeting and publication.
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