BMS and Janssen announced that Phase 3 Librexia collects data from more than 50,000 patients, including Librexia STROKE, Librexia ACS, and Librexia AF trials. Milvexian is an investigational oral factor XIa (FXIa) inhibitor (antithrombotic). Bristol Myers Squibb and Janssen have collaborated to develop milvexian.
The clinical trial program will comprise three randomized, double-blind, placebo-controlled Phase 3 clinical trials.
The first study, called the Librexia STROKE trial, milvexian in combination with standard of care, is under evaluation for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack.
The second trial is the Librexia ACS trial, which is aimed at evaluating the efficacy of milvexian for event reduction in acute coronary syndromes.
The Librexia AF trial aims to test the efficacy for preventing stroke in patients with atrial fibrillation. Milvexian will tested versus apixaban
BMS announced that the initiation of clinical trials marks a step forward in the development of a drug that has the potential to address an unmet medical need for patients at risk of thrombosis.