Bristol-Myers and Johnson & Johnson launch Phase 3 trial of milvexian

Bristol Myers Squibb (BMY), in collaboration with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson and Johnson (JNJ), announced the launch of the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa – FXIa – inhibitor. The Librexia program is the most comprehensive FXIa development program to date and will provide data from nearly 50,000 patients across three indication-seeking studies. 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. Phase 2 proof-of-concept data for milvexian demonstrated a differentiated antithrombotic profile as both a monotherapy and in combination with antiplatelet therapy. Librexia ACS and Librexia AF trials are expected to begin enrolling within the first half of 2023.