Bayer's Factor XIa Inhibitor Stroke Clinical Program Receives U.S. FDA Fast Track Designation

On February 10 , 2022 , Bayer announced that the U.
S.
Food and Drug Administration ( FDA ) has granted Fast Track designation to its investigational drug asundexian ( BAY2433334 ) as a potential treatment for secondary prevention of non-cardiac ischemic stroke patients .

On February 10 , 2022 , Bayer announced that the U.

S.

Bayer's asundexian is an oral factor XIa inhibitor for the secondary prevention of non-cardiac ischemic stroke, as well as the treatment of atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack)

Factor XIa inhibitors can specifically act on proteins involved in pathological thrombosis, while leaving pathways involved in physiological vascular healing unaffected, and thus may have the potential to prevent events such as stroke and myocardial infarction without a corresponding increase in bleeding risk.
potential

Fast Track designation is designed to facilitate the accelerated development of drug candidates for serious diseases to address unmet medical needs, with the goal of bringing important new treatments to patients earlier
.
Drug candidates that receive Fast Track designation have the opportunity to interact more frequently with the U.
S.
FDA to discuss development plans and, if they meet relevant criteria, qualify for accelerated approval and priority review
.
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