FDA Approves Flurpiridaz F 18 Diagnostic Drug for Coronary Artery Disease

The US Food and Drug Administration (FDA) has approved flurpiridaz F 18 (Flyrcado), an intravenous cyclotron-produced radioactive diagnostic drug, for evaluation of myocardial ischemia and infarction in adult patients.¹

The indication, granted to GE Healthcare, adds to the armamentarium of positron emission tomography (PET) products available for rest- or stress-based myocardial perfusion imaging (MPI) in adult patients with known or suspected coronary artery disease (CAD).

The application supporting flurpiridaz F 18 to the FDA included data from 2 prospective, multicenter, open-label clinical trials assessing the product’s efficacy and safety in patients with either suspected CAD (study 1) or known or suspected CAD (study 2). In the first study, investigators assessed the diagnostic drug’s sensitivity and specificity in detecting significant CAD in patients with suspected disease who were scheduled for invasive coronary angiography (ICA).

Investigators observed a sensitivity range of 74 - 89% for CAD (defined as ≥50% narrowing of the artery) across 3 imaging readers for the product, and a specificity range of 53 - 70%.

In the second trial, investigators assessed for flurpiridaz F 18’s sensitivity and specificity for significant CAD in the patients with known or suspected disease. Patients additionally had ICA without intervention within 60 days prior to the imagine, or were at least scheduled for the procedure. Investigators observed a sensitivty range of 63 - 77% for significant CAD, as well as a specificity range of 66 - 86%.

The most commonly reported adverse events in ≥2% of participants were dyspnea, headahce, angina pectoris, chest pain, fatigue, ST segment changes, and more. The label for Flyrcardo includes language stressing the associated risk of serious adverse events including myocardial infarction, arrhythmia, hypotension, bronc-constriction, stroke, and seizures due to exercise or pharmacologic stress.²

“When pharmacologic stress is selected, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information,” the label reads.

References

1. ^{U.S. Food and Drug Administration. FDA approves imaging drug for evaluation of myocardial ischemia and infarction. Press release. Published September 27, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-evaluation-myocardial-ischemia-and-infarction?utm_medium=email&utm_source=govdelivery}
2. ^{U.S. Food and Drug Administration. FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use. Prescribing Information. NDA 215168. Published 2024. Accessed September 27, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215168s000lbl.pdf}