FDA Approves Bayer's Asundexian for Secondary Stroke Prevention
The U.S. Food and Drug Administration (FDA) has granted approval to Bayer's asundexian (marketed as Sunharbo) for the prevention of secondary strokes. The treatment is indicated for patients who have recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). As a first-in-class Factor XIa inhibitor, asundexian is designed to be administered in combination with antiplatelet therapy. This regulatory milestone positions Bayer to enter the specialized market for stroke risk reduction through a novel mechanism of action.

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