SILVER SPRING, Md., Nov. 9 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor 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 Off...