Pharma Focus Asia

Bayer Announces U.S. FDA Fast Track Designation for Asundexian Atrial Fibrillation Programme

Tuesday, May 16, 2023

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF).

The OCEANIC clinical trial programme is designed to evaluate the use of oral FXIa inhibitor, asundexian, in patients with atrial fibrillation (AF) at risk of stroke and in patients with acute non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack (TIA), aiming to improve the benefit-risk profile when compared to current treatment options.

Asundexian is currently investigated as a candidate in an entirely new class of antithrombotic treatment options aiming to selectively modulate coagulation, address patients with concerns of bleeding, and focus on indications where current anticoagulation is not used.

Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body’s ability to respond to bleeding intact.

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