ASUNDEXIAN* AND FXIA INHIBITORS

Bayer Receives FDA Fast Track Designation for asundexian Stroke Program

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Thursday, February 10, 2022
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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.

Key Points: 
  • 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.
  • 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 candidates development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.5
    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.