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GUIDELINES/RECOMMENDATIONS Could this oral factor XIa inhibitor be the next big breakthrough in thrombotic disease treatment?
Milvexian, an investigational oral factor XIa (FXIa) inhibitor, has been granted Fast Track designation by the FDA for the potential treatment of ischemic stroke, acute coronary syndrome (ACS), and atrial fibrillation based on promising Phase 2 trial results.
Key Points:
- The FDA granted Fast Track designation to milvexian for three indications: ischemic stroke, ACS, and atrial fibrillation.
- This designation is backed by data from the phase 2 AXIOMATIC-TKR and AXIOMATIC-SSP trials.
- Milvexian demonstrated a positive antithrombotic profile, reducing the risk of postoperative venous thromboembolism and symptomatic ischemic strokes with a low incidence of bleeding.
Additional Points:
- Currently, milvexian’s efficacy and safety are being further investigated in the phase 3 Librexia development program.
- The Librexia program includes three phase 3 trials targeting stroke prevention:
- Post-acute ischemic stroke or high-risk transient ischemic attack (Librexia STROKE)
- Reducing the risk of major adverse cardiovascular event post-ACS (Librexia ACS)
- Reducing the risk of stroke and non-CNS systemic embolism in atrial fibrillation patients (Librexia AF)
Conclusion:
- The Fast Track designation for milvexian signals a potential significant advance in addressing the critical treatment needs in thrombotic events.
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“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.”
James F. List, MD, PhD
Global Therapeutic Area Head
Janssen Research & Development, LLC
