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 FDA. The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical development program to date and will provide extensive data from nearly 50,000 patients.
“Despite major advances in cardiovascular and stroke treatment over the past two decades, millions of patients currently remain untreated or undertreated due to the risk of bleeding, but for whom thrombotic events could be prevented,” said Robert Harrington, MD, Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine, Stanford University, Librexia program chair.i “If overlooked due to bleeding risk.”
All three indications being studied in the Phase 3 Librexia program were granted Fast Track Designation from the FDA. Fast Track Designation is intended to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical need for serious or life-threatening conditions. Fast Track Designation encourages close communication between the FDA and sponsor to improve the efficiency of product development, with the aim of getting new therapeutics to patients faster.
“This Fast Track Designation underscores the unmet need that exists in the treatment of thromboembolic conditions,” said Puneet Mohan, MBBS, MD, PhD, vice president, Global Program Lead, Milvexian, Bristol Myers Squibb. “The goal of milvexian and the Librexia program is to enhance the benefit-risk profile in the treatment of these conditions by delivering reduced thrombotic events and less bleeding in at-risk patients than the current standard of care.”
Phase 2 AXIOMATIC-TKR and AXIOMATIC-SSP proof-of-concept data for milvexian demonstrated a differentiated antithrombotic profile as both a monotherapy and in combination with antiplatelet therapy. These data also suggest a positive efficacy and bleeding profile in stroke patients where FXa inhibitors are not indicated.
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