The FDA has approved Bayer's Sunharbo (asundexian), an FXIa inhibitor that reduces the risk of secondary stroke.
The first approved drug in the class of Factor XIa inhibitors, Sunharbo is a once-daily, 50 mg tablet taken in combination with antiplatelet therapy. It is indicated for adults with recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack to reduce the risk of a subsequent stroke. Secondary strokes affect around one in five stroke survivors who have had a non-cardioembolic ischemic stroke and are often more severe than first strokes.
Approval for the drug is based on the phase 3 OCEANIC-STROKE study, in which treatment reduced secondary ischemic stroke by a statistically-significant extent compared to antiplatelet therapy alone. The clinical study also met its primary safety endpoint of International Society on Thrombosis and Hemostasis major bleeding.
Asundexian has also recently been approved by China’s National Medical Products Administration and has been submitted by Bayer for marketing authorization in additional markets around the world.