Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1), was designed to be a myocardial perfusion PET imaging agent for the diagnosis of CAD.
In March 2011, Lantheus received special protocol assessment approval from the US Food and Drug Administration for the Phase 3 trial of flurpiridaz F 18.
The primary objective of the study will be to evaluate the sensitivity and specificity of PET imaging with flurpiridaz F 18 as compared to SPECT imaging.
Lantheus Medical Imaging president and CEO Don Kiepert said PET myocardial perfusion imaging with flurpiridaz F 18 has the potential to evaluate patients with known or suspected coronary artery disease than SPECT imaging, and they look forward to initiate phase 3 clinical trials of this new clinical tool in the second quarter of this year.
