Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

Bayer:

WHAT’S HAPPENING

Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OCEANIC-STROKE trial. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine.

BAYER EXECUTIVE COMMENT

and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention,” said Yesmean Wahdan, M.D., Senior Vice President, U.S. Medical Affairs, Bayer. “We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.”

In 2023, asundexian was granted Fast Track Designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The FDA has now granted Priority Review for asundexian, a designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.¹

WHY THIS MATTERS

Stroke is the fifth leading cause of death in the United States.² Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.³ Despite current guideline recommendations for stroke prevention, a significant proportion of survivors experience another stroke.^4,5 Approximately one in five stroke survivors will have another stroke within five years.⁵

About FXIa
Factor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage.

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