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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Published by GSM · USA (original Chinese edition)
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