Johnson & Johnson Receives FDA Approval for Milvexian in Secondary Stroke Prevention

Johnson & Johnson today announced that the FDA has approved milvexian for the prevention of recurrent ischemic stroke in adults with acute ischemic stroke or transient ischemic attack. In the Phase 3 LIBREXIA-STROKE trial, milvexian demonstrated a statistically significant reduction in the risk of recurrent ischemic stroke compared to aspirin alone. Milvexian is an oral factor XIa inhibitor that provides anticoagulation with potentially lower bleeding risk than current anticoagulants. This approval provides patients with a new oral treatment option for secondary stroke prevention.