Posted by Michael Wonder on 19 May 2026
Bayer granted priority review by US FDA for asundexian in patients after a non-cardioembolic ischaemic stroke or transient ischaemic attack
19 May 2026 - Bayer today announced that the US FDA has accepted the company’s new drug application and granted priority review designation for its investigational oral factor XIa inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischaemic stroke or transient ischaemic attack.
The new drug application is based on positive results from the global, pivotal Phase 3 OCEANIC-STROKE trial.
