Bayer bags USFDA Fast Track Designation for asundexian Stroke Program

Berlin: Bayer has recently announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke.

Asundexian is currently being studied in the PACIFIC Phase II clinical trial program that consists of three Phase IIb studies in over 4,000 patients with one of the following three medical conditions: atrial fibrillation (irregular heartbeat), a recent non-cardioembolic ischemic stroke or a recent myocardial infarction (heart attack). By specifically targeting a protein involved in pathological thrombus formation, but leaving the pathway involved in physiological vessel healing intact, FXIa inhibitors could have the potential to prevent events like stroke and myocardial infarction (MI) without a corresponding increase in bleeding risk.

"This program is designed to provide further support for the hypothesis that inhibiting FXIa with asundexian can reduce the risk of thrombotic events without increasing the risk of bleeding," the company stated.

Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication.