Milvexian granted US FDA fast track designation for all three indications under evaluation in phase 3 Librexia programme
Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen), announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor, have now been granted Fast Track Designation by the US Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the phase 3 Librexia development programme (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia programme is unrivaled as the most comprehensive FXIa clinical development programme to date and will provide extensive data from nearly 50,000 patients.
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