FDA Approves Bayer's Sunharbo, First Factor XIa Inhibitor
The FDA approved Bayer's Sunharbo (asundexian), the first factor XIa inhibitor, on Nov. 9. The approval is based on the OCEANIC-STROKE trial, a phase 3 placebo-controlled study of 12,327 adults with a recent non-cardioembolic ischemic stroke or high-risk TIA, which found the drug reduced ischemic stroke risk by 26% versus placebo over a median 14.2 months when used with antiplatelet therapy. The drug carries higher major bleeding risk in patients over 75 and during the first 90 days of treatment, more frequent GI bleeding, and is not approved for stroke prevention in atrial fibrillation. It should be withheld before elective surgery and is not recommended with moderate-to-severe hepatic impairment or combined with strong P-gp and CYP3A4 inducers.