FDA Approves PET Imaging Agent for Suspected Coronary Artery Disease

The U.S. Food and Drug Administration (FDA) has approved flurpiridaz F-18 (Flyrcado; GE Healthcare), a first-of-its-kind positron emission tomography (PET) imaging agent, for use in adult patients with known or suspected coronary artery disease (CAD). CAD, the leading cause of death in the U.S., is a condition where the coronary arteries are narrowed or blocked, reducing blood flow to the heart and leading to serious conditions like myocardial ischemia and heart attacks.

Flurpiridaz F-18 is a nuclear medicine tracer used in myocardial perfusion imaging (MPI), a test that evaluates blood flow to the heart muscle under both rest and stress conditions. The drug, administered intravenously, allows doctors to detect abnormalities in blood flow, offering improved diagnostic accuracy compared to the current standard of single-photon emission computed tomography (SPECT) MPI. The longer half-life of flurpiridaz F-18 (109 minutes) extends its availability, enabling broader distribution compared to other PET cardiac tracers.

The drug’s safety and efficacy were confirmed in two large clinical trials, where it demonstrated a sensitivity of 74-89% and specificity of 53-70% in detecting significant CAD. The studies showed the drug’s potential to improve diagnosis, especially in hard-to-image patients, such as those with high body mass index and women, for whom traditional imaging can be less accurate.

“The approval of flurpiridaz F-18 marks a notable advancement in cardiac imaging by offering improved diagnostic accuracy, particularly for patients who are more difficult to image, such as those with a higher body mass index and women,” said Cathy Cutler, PhD, president of SNMMI. “Its offsite manufacturing and ready-to-use dose format could potentially broaden access to PET-MPI, while enhancing image quality and efficiency.”

GE Healthcare will release flurpiridaz F-18 under brand name Flyrcado in U.S. markets in early 2025, with expanding availability thereafter.

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