Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) announced the launch of the phase 3 Librexia programme studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic).
The Librexia programme is unrivaled as the most comprehensive FXIa development program to date and will provide important data from nearly 50,000 patients across three indication-seeking studies: Librexia STROKE, Librexia ACS and Librexia AF. Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023.