美国食药局11月9日批准首款XIa因子抑制剂Sunharbo：50毫克每日一次、联合抗血小板治疗，用于特定成人预防缺血性卒中复发，12,327人三期试验复发风险降低26%
华盛顿消息—美国食品药品管理局（FDA）11月9日批准拜耳的 Sunharbo（通用名 asundexian，阿苏地仙）上市。FDA 药品动态页将该批准列为「首款XIa因子抑制剂」批准。据 FDA 公告与路透社、STAT 等报道，该药为50毫克片剂、每日口服一次，与抗血小板治疗联合使用，适用于近期发生轻中度非心源性缺血性卒中、或高危短暂性脑缺血发作（TIA）的成人，以降低再次发生缺血性卒中的风险；获批对象为新泽西州惠帕尼的拜耳医疗保健制药公司（Bayer HealthCare Pharmaceuticals Inc.）。FDA 同时明确，该药未获批用于房颤患者的卒中预防。此次批准获快速通道与优先审评资格。
疗效依据为三期 OCEANIC-STROKE 试验：该随机、双盲、安慰剂对照试验在37个国家的702个中心共纳入12,327名成人，受试者为卒中后72小时内、美国国立卫生研究院卒中量表评分15分或以下者，或高危 TIA 患者。结果显示，在抗血小板治疗基础上加用 Sunharbo 的一组，再发缺血性卒中比例为6.2%，安慰剂组为8.4%，相对风险降低26%；STAT 与彭博社报道称，试验中大出血风险未见显著上升。该试验结果已于2026年4月发表于《新英格兰医学杂志》。
FDA 药物评价与研究中心心脏病学、血液学、内分泌学与肾脏病学办公室主任海尔顿·V·乔菲（Hylton V. Joffe）表示：「卒中是美国致残与死亡的主要原因之一，幸存者面临再次卒中的风险。今天的批准对寻求二级卒中预防新选择的患者与医疗提供者而言，是一项有意义的进步。」据路透社报道，中国药品监管部门已于10月下旬批准 asundexian，美国为第二个批准该药的主要市场；该药30天用量的标价为748.50美元。本稿仅报道批准事实与试验数据，不作个体用药建议。
FDA Approves Sunharbo, the First Factor XIa Inhibitor, on November 9: A 50 mg Once-Daily Tablet Used With Antiplatelet Therapy to Prevent Recurrent Ischemic Stroke in Certain Adults, After a 12,327-Patient Phase 3 Trial Showed a 26 Percent Risk Reduction
WASHINGTON — The U.S. Food and Drug Administration on November 9 approved Bayer's Sunharbo (asundexian). The FDA's drug updates page lists the action as the approval of the first Factor XIa inhibitor. According to the FDA announcement and reporting by Reuters and STAT, the drug is a 50 mg tablet taken once daily, used together with antiplatelet therapy in adults who have had a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), to reduce the risk of another ischemic stroke; the approval was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey. The FDA stated that Sunharbo is not approved for stroke prevention in patients with atrial fibrillation. The application received Fast Track and Priority Review designations.
The approval rests on the Phase 3 OCEANIC-STROKE trial, a randomized, double-blind, placebo-controlled study that enrolled 12,327 adults at 702 centers in 37 countries, within 72 hours of a non-cardioembolic ischemic stroke with a National Institutes of Health Stroke Scale score of 15 or less, or a high-risk TIA. Recurrent ischemic stroke occurred in 6.2 percent of patients who received Sunharbo on top of antiplatelet therapy, versus 8.4 percent on placebo, a 26 percent relative risk reduction; STAT and Bloomberg reported that the trial showed no significant increase in major bleeding. The trial results were published in the New England Journal of Medicine in April 2026.
"Stroke is a leading cause of disability and death in the United States, and survivors are at risk of having another stroke," said Hylton V. Joffe, director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA's Center for Drug Evaluation and Research. "Today's approval represents a meaningful advance for patients and health care providers seeking a new option for secondary stroke prevention." According to Reuters, China's drug regulator approved asundexian in late October, making the United States the second major market to clear it; the drug's list price is $748.50 for a 30-day supply. This report states the approval facts and trial data only and offers no individual treatment advice.
来源链接：美国食药局药品动态页（2026-11-09 条目，fda.gov）： https://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs ；路透社批准报道（2026-11-09）： https://www.reuters.com/legal/litigation/us-fda-approves-bayers-blood-thinner-prevent-repeat-strokes-2026-11-09/
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