GE Healthcare, the healthcare business of conglomerate General Electric Co. (GE), along with Lantheus Holdings Inc. (LNTH) announced Tuesday that the recent Phase III clinical trial of their investigational radiotracer, Flurpiridaz (18F), has met its co-primary endpoints.
In the trial, the Flurpiridaz Positron Emission Tomography or PET radiotracer exceeded a 60 percent threshold for both sensitivity and specificity for detecting Coronary Artery Disease or CAD.
Francois Tranquart, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, said the positive Phase III trial results are a key step towards future approval of Flurpiridaz (18F) Injection as a potential new cardiac PET agent which could improve the detection of CAD.
The findings also demonstrate Flurpiridaz (18F) PET has higher diagnostic efficacy and image quality in patients with suspected CAD, compared with Single Photon Emission Computed Tomography or SPECT Myocardial Perfusion Imaging (MPI), the predominant procedure used in nuclear cardiology at present.
SPECT MPI represents around 6 million procedures per year in the U.S.
The findings were shared at the American Society of Nuclear Cardiology or ASNC Congress, in Florida, U.S.
The companies noted that the Phase III Open-Label Study involved over 600 patients across sites in the U.S., Europe and Canada. It assessed the diagnostic efficacy of [18F]flurpiridaz in detecting CAD, the most common form of heart disease and the leading cause of death globally.
If approved, the investigational agent would offer the advantages of 18F, with broad available distribution and a half-life of almost two hours, removing the need for it to be manufactured in the immediate vicinity of the imaging department.
This longer half-life could also make Flurpiridaz (18F) Injection suitable for exercise stress testing, which is not feasible with existing cardiac PET radiotracers.
GE Healthcare has led the funding and development of [18F]flurpiridaz. If the imaging agent is approved, the company will have global commercialization rights.
Lantheus has collaborated on the development and will also collaborate on potential commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales.
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