The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Programme
Thursday, March 02, 2023
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).
Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia programme, the most comprehensive FXIa clinical development programme today.
Librexia ACS is a randomised, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian after a recent acute coronary syndrome.
The Librexia programme is a first-of-its-kind clinical programme, with three Phase 3 trials running concurrently aims to investigate whether milvexian can improve the benefit-risk profile in thrombotic care by delivering reduced thrombotic events with less bleeding for more patients in need
The depth and breadth of the Librexia clinical development programme will capture data in three related but distinct areas of clinical need related to residual risk of thrombotic events and patient bleeding, and evaluate milvexian’s potential to advance beyond the current standard of care and improve patient outcomes in acute coronary syndromes, atrial fibrillation and ischaemic stroke.
