The Food and Drug Administration (FDA) has granted Fast Track designation to milvexian across 3 indications including ischemic stroke, acute coronary syndrome (ACS), and atrial fibrillation.
Milvexian is an investigational oral factor XIa (FXIa) inhibitor. The designation is supported by data from the phase 2 AXIOMATIC-TKR and AXIOMATIC-SSP trials, which showed that milvexian had a favorable antithrombotic profile as both a monotherapy and in combination with antiplatelet therapy. In these trials, milvexian reduced the risk of postoperative venous thromboembolism and symptomatic ischemic strokes, respectively, with a low incidence of bleeding.
The Company is currently investigating the efficacy and safety of milvexian in the phase 3 Librexia development program. The program consists of three phase 3 trials:
- Librexia STROKE (ClinicalTrials.gov Identifier: NCT05702034) for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack;
- Librexia ACS (ClinicalTrials.gov Identifier: NCT05754957) to reduce the risk of major adverse cardiovascular event (MACE) in patients after a recent ACS; and
- Librexia AF (ClinicalTrials.gov Identifier: NCT05757869) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with atrial fibrillation.
“For milvexian to receive Fast Track Designation from the FDA for all 3 indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, like heart attack and stroke,” said James F. List, MD, PhD, 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.”
- Milvexian granted US FDA Fast Track designation for all three indications under evaluation in phase 3 librexia program: ischemic stroke, acute coronary syndrome and atrial fibrillation. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. Accessed May 25, 2023. https://www.prnewswire.com/news-releases/milvexian-granted-us-fda-fast-track-designation-for-all-three-indications-under-evaluation-in-phase-3-librexia-program-ischemic-stroke-acute-coronary-syndrome-and-atrial-fibrillation-301834509.html.