The FDA approved a pill that cut repeat strokes by 26%
Sunharbo (asundexian), the first factor XIa inhibitor, was approved for adults after a recent mild-to-moderate ischemic stroke or high-risk TIA, based on a 12,327-patient Phase 3 trial.
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The Food and Drug Administration approved Sunharbo, also called asundexian, the first factor XIa inhibitor cleared for this use, the agency announced from Silver Spring. The approval is for adults who have had a recent mild-to-moderate ischemic stroke or a high-risk transient ischemic attack. In a Phase 3 trial of 12,327 patients, the pill cut repeat strokes by 26 percent. That result is what the approval rests on. It applies to the adults in that indication, not to everyone who worries about a stroke, and it is not a cure. A decision about the drug belongs with a patient's own clinician.
Health & Tech in MarylandSilver Spring, MarylandMedical researchPublic healthGood news on November 10
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