(News Bulletin 247) – Bayer today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug asundexian as a potential treatment to prevent strokes and systemic embolisms in people with atrial fibrillation.
This news follows asundexian’s first US FDA Fast Track Designation for the prevention of stroke in patients with non-cardioembolic ischemic stroke, which was granted in 2022.
Asundexian is an investigational agent that has not been approved for use by any health authority in any country. It is currently being evaluated as a potential factor XIa (FXIa) inhibitor given orally once daily in the prevention of thrombosis.
‘Asundexian is currently being studied as a candidate in an entirely new class of antithrombotic treatment options aimed at modulating coagulation, addressing patient concerns and focusing on indications where current anticoagulation is not used’, underlines Christian Rommel, member of the executive committee of the pharmaceutical division of Bayer AG and responsible for research and development.
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