SILVER SPRING
Asundexian NDA accepted under priority review
- Sponsor
- Bayer $BAYRY
- Drug
- asundexian
- Indication
- thromboembolic event prevention
FDA accepted Bayer's NDA for Factor XIa inhibitor asundexian for prevention of thromboembolic events.
What this means
Asundexian is a blood thinner that works by blocking Factor XIa, a protein involved in clot formation, potentially reducing stroke risk without increasing bleeding. The FDA has agreed to fast-track its review of Bayer's application for preventing dangerous blood clots. If approved, asundexian could offer a new option for patients at risk of stroke or other clot-related complications, particularly those who need alternatives to current anticoagulants.