FDA Fast Track Designation for all three prospective indications for FXIa inhibitor
FDA Fast Track Designation has been granted to all three prospective indications -ischemic stroke, ACS and atrial fibrillation- for the investigational oral factor XIa (FXIa) inhibitor milvexian. Three phase 3 studies are underway in the Librexia program evaluating milvexian: Librexia STROKE, Librexia ACS and Librexia AF.
“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”, as written in the press release.
Previously, results of the phase 2 studies AXIOMATRIC-TKR and AXIOMATTIC-SSP evaluating milvexian were presented. Milvexian is a oral factor XIa inhibitor that is currently under investigation for the prevention and treatment of major thrombotic conditions.