FDA approves Bayer's Sunharbo, first Factor XIa inhibitor, for secondary stroke prevention
- FDA approved Bayer's once-daily oral Sunharbo (asundexian) on Nov. 9, the first Factor XIa inhibitor cleared, for adults with a prior warning stroke or non-cardiac clot-related stroke, alongside antiplatelet therapy.
- In a pivotal trial of 12,000+ adults, ischemic stroke risk fell 26% versus placebo with similar major bleeding; diarrhea was the most common adverse reaction.
- List price is $748.50 per 30 days; launch starts with stroke neurologists.
💡 Points Based on public reports
Factor XIa has been the industry's great hope for bleeding-sparing anticoagulation, so a first approval matters, but this label is narrow: secondary stroke prevention on top of antiplatelets, not the AF market where Eliquis dominates. Watch how Bayer sequences further indications, and how Novartis and others' XIa programs respond.