Bayer has announced that the US 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 who have had a non-cardioembolic ischaemic stroke or transient ischaemic attack (TIA).
The NDA is based on positive results from the global, pivotal, phase-three OCEANIC-STROKE trial—which were presented at the 2026 International Stroke Conference (ISC; 4–6 February, New Orleans, USA) and have also been published in the New England Journal of Medicine. OCEANIC-STROKE met both its primary efficacy endpoint of time to first occurrence of ischaemic stroke and its primary safety endpoint of time to International Society on Thrombosis and Haemostasis (ISTH) major bleeding.
“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,” said Yesmean Wahdan, senior vice president of US Medical Affairs at Bayer. “We are proud of this important milestone that builds on our longstanding commitment to innovation in antithrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.”
In 2023, asundexian was granted a fast-track designation by the US FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischaemic stroke. Now, the drug has also received a priority review designation, which is intended to further accelerate the evaluation of medicines that—if approved—may provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis, of a serious condition.
