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New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anti

New study includes patients aged ≥65 years with atrial fibrillation (AF) at high risk for ischemic stroke or systemic embolism who are deemed ineligible for oral anticoagulant (OAC) treatment due to increased risk of bleedingOCEANIC-AFINA, the latest Phase III study in the OCEANIC clinical trial program, will invest. ....

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Bayer Receives U.S. FDA Fast Track Designation for asundexian Atrial Fibrillation Program

Bayer Receives U.S. FDA Fast Track Designation for asundexian Atrial Fibrillation Program
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Milvexian Fast Tracked for Ischemic Stroke, Acute Coronary Syndrome, and Atrial Fibrillation

The FDA has granted Fast Track designation to milvexian across 3 indications including ischemic stroke, ACS, and atrial fibrillation. ....

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Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients,. | May 25, 2023 ....

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