Bayer receives FDA approval for Sunharbo stroke prevention drug

The US Food and Drug Administration has approved Bayer’s asundexian, marketed as Sunharbo, to reduce the risk of recurrent stroke in adults following a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). As the first approved factor XIa inhibitor, the once-daily 50 mg tablet is intended for use in combination with antiplatelet therapy.

The approval is based on the phase 3 OCEANIC-STROKE trial, which involved over 12,000 participants. Data showed that asundexian reduced the relative risk of ischemic stroke by 26 percent compared to a placebo. While major bleeding rates were generally similar to the control group, the FDA noted an increased risk in patients over 75 and during the first 90 days of treatment. Common adverse reactions included diarrhea.

This regulatory milestone follows a previous approval in China and serves as a strategic move for Bayer to offset declining revenues from older blockbuster medicines like Xarelto and Eylea, which have faced competition from generics following patent expirations. Analysts note that while the drug represents a significant innovation in the pharmaceutical pipeline, its market potential may be limited by its specific indication, which covers approximately 40 percent of stroke cases.