Bayer Receives FDA Fast Track Designation for asundexian Stroke Program

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 Eleven (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 medical conditions: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack).  Asundexian is currently in Phase II clinical trials in all three conditions either as a standalone therapy or in combination with anti-platelet therapy.

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 FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

“We are pleased that asundexian has received Fast Track Designation from the FDA, underscoring the urgent need for additional effective therapies to treat secondary stroke prevention,” said Hardi Mundl, M.D., group head thrombosis, clinical development and operations, Bayer. “This step aligns with Bayer’s long-standing commitment to advance a portfolio of treatment approaches for cardiovascular disease where significant medical need exists.”