FDA approves Bayer's drug to reduce stroke recurrence

The FDA approved Sunharbo, Bayer's novel drug to reduce stroke recurrence, on Monday. In Phase 3 trials, 6.2% of patients taking Sunharbo experienced a secondary stroke compared to 8.4% on placebo—a 26% risk reduction. The drug inhibits the protein XIa and is thought to prevent blood clots without increasing bleeding risk, addressing a major gap where existing blood thinners were too dangerous for this use.

This is early data from one Phase 3 trial. Real-world outcomes as more patients use the drug will take time to emerge.