FDA Approves Sunharbo, First Factor XIa Inhibitor: Recurrent Stroke Risk Cut 26% in Trial
WASHINGTON — The U.S. Food and Drug Administration (FDA) on November 9 approved Sunharbo (asundexian) 50 mg tablets. It is the first factor XIa (FXIa) inhibitor approved in the United States, for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke, a stroke caused by a clot that did not originate in the heart, or a high-risk transient ischemic attack (TIA), often called a mini-stroke.
"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, M.D., MMSc, 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."
The approval was based on OCEANIC-STROKE, a multicenter, randomized, double-blind, placebo-controlled phase 3 study that enrolled 12,327 adults. Participants had a recent non-cardioembolic ischemic stroke (NIH Stroke Scale score of 15 or less) or a high-risk TIA and were randomly assigned to Sunharbo or placebo within 72 hours of symptom onset, with both groups also receiving antiplatelet therapy. Sunharbo 50 mg once daily significantly reduced the risk of ischemic stroke by 26% compared with placebo over a median treatment period of 14.2 months.
On safety, the overall rate of major bleeding was similar between the Sunharbo and placebo groups, but it was increased with Sunharbo in patients older than 75 years and during the first 90 days of treatment. Gastrointestinal bleeding occurred more commonly with Sunharbo than with placebo. The most frequently reported adverse reaction, occurring in 3% or more of Sunharbo-treated patients, was diarrhea.
The FDA also set out several limits on use. Concomitant use with medicines that are combined P-gp and strong CYP3A4 inducers, such as carbamazepine, is not recommended because they may decrease Sunharbo's effectiveness. Sunharbo is not recommended in patients with moderate or severe hepatic impairment. It should be withheld at least 24 hours before elective surgery or invasive procedures and for at least 24 hours after thrombolysis for acute ischemic stroke. Sunharbo is not approved for stroke prevention in patients with atrial fibrillation.
The FDA had granted Sunharbo Fast Track and Priority Review designations. The approval was granted to Bayer HealthCare Pharmaceuticals Inc. of Whippany, New Jersey. According to Reuters, China's drug regulator approved the drug late last month.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
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