Bayer Receives U.S. FDA Fast Track Designation for asundexian Stroke Program
Friday, February 11, 2022
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 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 secondary prevention in patients with a non-cardioembolic ischemic stroke as well as for two additional conditions: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack). Asundexian is currently in Phase II clinical trials in all three indications either as a standalone therapy, or in combination with anti-platelet therapy. Inhibition of FXIa by asundexian is hypothesized to provide protection from thrombotic events without increasing the risk of bleeding.
Fast Track Designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfill unmet medical needs. The purpose of the program is to get important new therapeutics to the patient earlier. A drug candidate that receives Fast Track Designation may be eligible for more frequent interactions with the U.S. FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
