GE Healthcare and Lantheus Phase III Clinical Trial Finds [18F]flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease

Wednesday, September 14, 2022

GE Healthcare and Lantheus Holdings Inc have jointly announced the successful Phase III clinical trial results for their investigational radiotracer, [18F]flurpiridaz, in detecting Coronary Artery Disease (CAD). The trial met its co-primary endpoints by exceeding a 60 percent threshold for both sensitivity and specificity. These findings, presented at the American Society of Nuclear Cardiology (ASNC) Congress, showcase the superior diagnostic efficacy and image quality of [18F]flurpiridaz Positron Emission Tomography (PET) compared to the current standard procedure of Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in patients with suspected CAD.

The Phase III Open-Label Study involved over 600 patients across multiple sites in the US, Europe, and Canada. It assessed the diagnostic efficacy of [18F]flurpiridaz in detecting CAD, which is the most prevalent form of heart disease and a leading cause of death worldwide. CAD affects over 120 million people globally each year, with approximately 20 million adults in the US alone. If approved, this investigational agent would offer advantages such as 18F's broad distribution availability and longer half-life, making it suitable for exercise stress testing, which is currently not feasible with existing cardiac PET radiotracers.

Dr. Tim Bateman, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke's Hospital, expressed enthusiasm for the results, stating that [18F]flurpiridaz has the potential to expand the use of PET MPI for imaging CAD patients, aligning with the ideal myocardial perfusion tracer specifications outlined by ASNC.

Dr. Francois Tranquart, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, emphasized the significance of these positive Phase III trial results as a key step towards future approval of Flurpiridaz (18F) Injection. GE Healthcare, the primary funder and developer of [18F]flurpiridaz, will hold global commercialization rights if the imaging agent receives approval. Lantheus, the collaborative partner, will also contribute to potential commercialization through a joint steering committee and receive royalties based on commercial sales.

GE Healthcare's Pharmaceutical Diagnostics unit, a global leader in imaging agents, supports approximately 100 million procedures annually, covering cardiology, neurology, and oncology. Their Molecular Imaging portfolio combines innovative pipeline products with established proprietary offerings to enhance diagnostic accuracy and improve patient outcomes.

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