Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack
Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack
KEY FACTS:
Regulatory submission is based on positive results from the Phase III OCEANIC-STROKE study
OCEANIC-STROKE met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding
Bayer:
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