FDA Grants Fast Track Designation to Milvexian for Multiple Prospective Cardiovascular Indications


The proposed indications for milvexian include stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack; recent acute coronary syndrome; and atrial fibrillation.

The FDA has granted fast track designation to 3 prospective indications for Janssen Pharmaceutical and Bristol Myers Squibb’s milvexian, an oral factor Xla inhibitor.

3d rendered illustration of heart attack and heart disease 3D illustration | Image Credit: santoelia - stock.adobe.com

santoelia - stock.adobe.com

The indications include stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack, recent acute coronary syndrome, and atrial fibrillation.

“Despite major advances in cardiovascular and stroke treatment over the past 2 decades, millions of patients currently remain untreated or undertreated due to the risk of bleeding, but for whom thrombotic events could be prevented,” Robert Harrington, MD, Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine at Stanford University, said in a statement. “If successful, milvexian could open the door to treat an entirely new set of patients who are currently overlooked due to bleeding risk.”

The designation is supported by 3 studies within the phase 3 Librexia development program, which include Librexia STROKE (NCT05702034), Librexia ACS (NCT05754957), and Librexia AF (NCT05757869). The Librexia program consists of nearly 50,000 individuals.

The Librexia program is currently considered the most comprehensive FXla clinical development program to date, which was implemented after positive phase 2 efficacy and safety data. The program is intended to investigate whether the drug can enhance the benefit-risk profile in the intended-to-treat population.

Librexia STROKE is a phase 3 randomized, double-blinded study to determine the efficacy and safety of milvexian, in addition to a single or dual antiplatelet therapy, for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack.

Additionally, in Librexia ACS, investigators sought to determine the safety and efficacy of milvexian after a recent acute coronary syndrome, whereas Librexia AF evaluated the efficacy and safety of milvexian for those with atrial fibrillation compared to apixaban.

“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,” James F. List, MD, PhD, global therapeutic area head at Janssen Research & Development, LLC, said in the statement. “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.”

Furthermore, the phase 2 AXIOMATIC-TRK (NCT03891524) and AXIOMATIC-SSP (NCT03766581) demonstrated a differentiated antithrombotic profile for the drug as both a monotherapy and in combination with antiplatelet therapy. The data also indicted a positive efficacy and bleeding profile in stroke patients for whom FXa inhibitors are not indicated.

Fast track designation is intended to help expediate the process of drug development and review timelines. It is given to drugs with preliminary nonclinical and clinical evidence that shows a substantial improvement over available therapies, which address unmet medical needs for serious or life-threatening conditions.

Milvexian has not yet been approved in any country or for any indication.


Milvexian granted US FDA fast track designation for all 3 indications under evaluation inphase 3 Librexia program: ischemic stroke, acute coronary syndrome, and atrial fibrillation. News release. Johnson and Johnson. May 25, 2023. Accessed June milvexian. https://www.jnj.com/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

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