FDA批准拜耳口服药Sunharbo：首个凝血因子XIa抑制剂用于卒中二级预防
美国食品和药物管理局已批准拜耳公司的口服药asundexian（商品名Sunharbo）上市。这是首个获批用于卒中二级预防的凝血因子XIa抑制剂，规格为50毫克片剂，每日口服一次，与抗血小板治疗联用，用于近期发生轻至中度非心源性缺血性卒中（NIHSS评分不高于15分）或高危短暂性脑缺血发作（TIA）的成人患者，以降低卒中复发风险。
此次批准依据三期临床试验OCEANIC-STROKE（注册号NCT05686070）的结果。该试验显示，asundexian可降低缺血性卒中的复发，且大出血风险未见统计学意义上的显著增加。
药品说明同时划定了使用边界：该药不用于心房颤动患者的卒中预防，中重度肝损伤患者不推荐使用；拟行择期手术或侵入性操作前至少停药24小时，急性缺血性卒中接受溶栓治疗后至少24小时再恢复用药。
凝血因子XIa位于凝血通路的上游，抑制这一靶点被认为有可能在降低血栓风险的同时减少出血。Sunharbo获批后，卒中二级预防领域首次出现这一作用机制的口服药物。
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.
来源：美国食品和药物管理局
发布：GSM·美国（发布链接）
图片来源：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.
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