Bayer recently announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review (PR) 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 3 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.

Yesmean Wahdan, MD, Senior Vice President, US Medical Affairs, Bayer, said, “Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention. 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.