WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today 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). This news follows asundexian’s first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022.
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced the first patients have been enrolled in the initial trials for its OCEANIC clinical trial program, designed to explore the use of asundexian (BAY2433334), an investigational oral Factor XIa (FXIa) inhibitor, in patients with atrial fibrillation (AF) and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), a temporary period of symptoms similar to those of a stroke.1-2 Asundexian belongs to a potential new class of drugs being studied for thrombosis prevention.1-2 OCEANIC is one of the largest Phase III endeavors Bayer has ever undertaken.3
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced the start of a Phase III clinical development program “OCEANIC” to investigate the efficacy and safety of asundexian (BAY 2433334), an investigational oral Factor XIa (FXIa) inhibitor, in patients with atrial fibrillation (irregular heartbeat) and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (a stroke that lasts only a few minutes).1,2