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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 an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment for...
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.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751