> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bayer Gets Priority Review for Stroke Drug
- URL: https://www.fdaweb.com/bayer-gets-priority-review-for-stroke-drug/
- Published: 2026-05-19T12:00:00.000Z
- Updated: 2026-09-14T13:39:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161169

FDA has granted Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the risk of recurrent stroke in patients who have experienced a non-cardioembolic ischemic stroke or transient ischemic attack. The submission is based on data from the Phase 3 OCEANIC-STROKE trial, which met both its primary efficacy endpoint — time to first occurrence of ischemic stroke — and its primary safety endpoint measuring International Society on Thrombosis and Hemostasis major bleeding events.

The investigational therapy targets Factor XIa, a component of the coagulation cascade that researchers believe plays a larger role in pathologic clot formation than in normal blood clotting, according to the company.