The FDA on Nov. 9 approved Sunharbo (asundexian), a once-daily 50 mg pill from Bayer, to lower the risk of another stroke in adults who recently had a mild-to-moderate ischemic stroke or a high-risk transient ischemic attack, often called a mini-stroke. It is the first factor XIa inhibitor approved in the United States and is taken along with antiplatelet medicine, according to the FDA announcement.
In the trial behind the approval, 6.2% of people taking Sunharbo with standard antiplatelet medicine had another ischemic stroke, compared with 8.4% of those taking a placebo with their antiplatelet drugs. The FDA described that as a 26% lower risk over a median of 14.2 months of treatment.
