FDA Approves Bayer's Sunharbo (Asundexian), First Factor XIa Inhibitor for Secondary Stroke Prevention
The U.S. Food and Drug Administration has approved Bayer's oral drug asundexian, sold as Sunharbo, the first factor XIa inhibitor cleared for secondary stroke prevention. The 50 mg tablet is taken once daily together with antiplatelet therapy in adults who have had a recent mild-to-moderate non-cardioembolic ischemic stroke (NIHSS score of 15 or less) or a high-risk transient ischemic attack, to lower the risk of another stroke.
The approval rests on the phase 3 OCEANIC-STROKE trial (NCT05686070), in which asundexian reduced recurrent ischemic stroke without a statistically significant increase in major bleeding.
The labeling sets clear limits. The drug is not indicated for stroke prevention in patients with atrial fibrillation, and it is not recommended in moderate to severe hepatic impairment. It should be held for at least 24 hours before elective surgery or invasive procedures, and for at least 24 hours after thrombolytic therapy for acute ischemic stroke.
Factor XIa sits upstream in the clotting cascade, and inhibiting it has been studied as a way to reduce thrombosis with less bleeding. Sunharbo's approval brings the first oral drug with this mechanism into secondary stroke prevention.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：拜耳位于德国 Leverkusen 的工厂（航拍）。来源：Rolf Heinrich, Köln，Wikimedia Commons，CC BY 3.0。 / Photo: Bayer plant in Leverkusen, Germany (aerial view). Source: Rolf Heinrich, Köln, Wikimedia Commons, CC BY 3.0.
