Flurpiridaz F 18
A Novel PET Cardiac Imaging Agent
Flurpiridaz F 18 is our most advanced agent in development, with the first of two Phase 3 trials complete. Flurpiridaz F 18 is an investigational positron emission tomography (PET) myocardial perfusion imaging (MPI) agent that may help better evaluate coronary artery disease (CAD), the most common form of heart disease, which affects an estimated 15.5 million Americans 20 years of age or older.
- Higher image quality
- Increased diagnostic certainty
- More accurate risk stratification
- Reduced patient radiation exposure
In May 2015, we announced the complete results from the first Phase 3 trial (study 301).
Based on these results, we have redesigned the protocol for our second Phase 3 trial with different primary endpoints. On March 13, 2015, the FDA granted us a Special Protocol Assessment (SPA) in connection with the new (study 303) trial.
Next steps for this promising diagnostic imaging agent
On April 25, 2017, Lantheus entered into a definitive agreement with GE Healthcare for the continued Phase 3 development and worldwide commercialization of flurpiridaz F 18. Under the definitive agreement, GE Healthcare will complete the development program of flurpiridaz F 18, including the second Phase 3 clinical study, pursue worldwide regulatory approvals and, if successful, lead a worldwide launch and commercialization of the agent, with LMI collaborating on both development and commercialization through a joint steering committee.
- Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.
- Berman, D.S., Maddahi,J., et al. Phase II Safety and Clinical Comparison with Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease: Flurpiridaz F 18 Positron Emission Tomography. J AM Coll Cardiol. 2013 Jan; 61(4):469-77.