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Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation

Friday, May 26, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (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, M.D., Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine, Stanford University, Librexia program chair.i "If successful, milvexian could open the door to treat an entirely new set of patients who are currently 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. 

"For milvexian to receive Fast Track Designation from the FDA for all three indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, like heart attack and stroke," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs, including milvexian, at Janssen Research & Development, LLC. "We are now focused on enrolling patients to these trials with urgency, bringing us one step closer to potentially improving outcomes in a wide range of patients with thrombotic diseases." 

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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