FDA Approves Bayer’s SUNHARBO for Stroke-Risk Reduction
The FDA approved Bayer’s asundexian 50 mg tablets, in combination with antiplatelet therapy, to reduce stroke risk in adults with recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Story updates
01:11:23 AM UTC
SquawkNews
The FDA approved Bayer’s SUNHARBO with antiplatelet therapy to reduce stroke risk in eligible adults. In Phase 3 OCEANIC-STROKE, ischemic stroke occurred in 6.2% with SUNHARBO versus 8.4% with placebo; HR 0.74.Material DetailsContext by AI AnalystThis is a commercial milestone for a new medicine, s…
BayerBayer’s SUNHARBO® (asundexian), 50 mg tablets, the First and Only Factor XIa Inhibitor, Approved by the U.S. FDA to Reduce the Risk of Stroke in Adults With Recent Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack, in Combination With Antiplatelet TherapyThis press relea…