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Abelacimab Reduces Major, Clinically Relevant Non-Major Bleeding Compared WIth Rivaroxaban
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Key Takeaways
- Abelacimab reduced major or clinically relevant non-major bleeding by 62% compared to rivaroxaban in atrial fibrillation patients.
- The study included patients aged 55 and older with atrial fibrillation or atrial flutter, excluding those with certain bleeding risks.
Abelacimab (Anthos Therapeutics Inc) is a novel factor XI inhibitor being investigated for the reduction of bleeding for patients with atrial fibrillation.
Abelacimab (Anthos Therapeutics Inc), a novel factor XI inhibitor, reduced major or clinically relevant non-major bleeding by approximately 62% compared with rivaroxaban (Xarelto; Johnson & Johnson) for patients with atrial fibrillation, according to results of the AZALEA-TIMI 71 (NCT04755283) study published in the New England Journal of Medicine.1
Abelacimab reduces major and clinically relevant non-major bleeding by 62%. | Image Credit: DIgilife | stock.adobe.com
“Many [physicians] are put in the unfortunate position of having to weigh the risk of stroke against the risk of bleeding for their patients with [atrial fibrillation],” Christian T. Ruff, MD, MPH, director of general cardiology at Brigham and Women’s Hospital, said in a news release. “This study reinforces the promise of abelacimab as a potentially safer alternative to current anticoagulants to address the risk of bleeding.”1
In the study, investigators included patients 55 years and older who had a history of atrial fibrillation or atrial flutter with planned indefinite anticoagulation. Patients were not included if they had a history of hypersensitivity to any drugs included in the study, intracranial or intraocular bleeding prior to screening, mechanical heart valve, or any other indication for anticoagulation that is not atrial fibrillation. Investigators divided patients into low, medium, or high abelacimab groups or rivaroxaban. The primary end point included reductions in major or clinically relevant non-major bleeding events from randomization through study completion (an average of 17 months). Secondary end points included time to first International Society on Thrombosis and Haemostasis-defined bleeding events and major or minor bleeding events.2
Investigators reported that the study drug showed significant reductions in major bleeding by 67% and an 89% reduction in gastrointestinal bleeding. Additionally, the median 99% inhibition was sustained over 2 years with abelacimab dosed once monthly. The median follow-up time for the study was 21 months, which makes it the longest head-to-head study for factor XI inhibitors.1
“Building on the overwhelmingly positive data from the AZALEA study, data on the safety of abelacimab in patients undergoing surgical procedures as well as data in patients taking antiplatelet therapy further reinforce the fundamental premise of the promise of Factor XI inhibition—the potential to prevent thrombotic events without affecting normal hemostasis,” Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics, said in a news release. “Even when the risk of bleeding is highest, during surgery or invasive procedures or when using antiplatelet therapy, patients treated with abelacimab have a very low rate of bleeding, despite near complete inhibition of factor XI.”1
Previously, data for the study were presented as late breaking at the American Heart Association 2024 Scientific Sessions. The data showed there was an incident rate of 10.6% for rivaroxaban compared with 3.5% for abelacimab. Furthermore, the absolute rate of bleeding was higher with rivaroxaban combined with antiplatelet therapy at 10.6%, versus 7.7% with rivaroxaban alone.3
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