FDA Approves New PET Imaging Agent for Coronary Heart 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 a known or suspected coronary artery. disease (CAD). Coronary artery disease, the leading cause of death in the United States, is a disease in which the coronary arteries are narrowed or blocked, reducing blood flow to the heart and leading to serious illnesses such as 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 resting and stressed conditions. The drug, administered intravenously, allows doctors to detect blood flow abnormalities, providing 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, allowing for wider distribution compared to other PET cardiac tracers.

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

The approval of flurpiridaz F-18 marks a notable advancement in cardiac imaging by providing improved diagnostic accuracy, particularly for more difficult to image patients, such as those with higher body mass indexes and women. Its off-site manufacturing and ready-to-use dose format could potentially expand access to PET-MPI, while improving image quality and efficiency. »

Cathy Cutler, PhD, President of SNMMI

GE Healthcare will launch flurpiridaz F-18 under the Flyrcado brand in U.S. markets in early 2025, with increasing availability thereafter.