FDA Approves First FXIa Inhibitor Sunharbo to Reduce Risk of Recurrent Stroke in Certain Patients
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On November 9, the U.S. FDA approved Bayer's asundexian tablets (brand name Sunharbo) as an adjunct to antiplatelet therapy to reduce the risk of recurrent stroke in adults who have recently experienced a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). TIA is commonly referred to as a "mini-stroke." This approval covers secondary prevention after stroke; it does not apply to all patient populations and does not include stroke prevention in patients with atrial fibrillation.