On September 27, 2024, the U.S. Food and Drug Administration (FDA) approved Flyrcado (flurpiridaz F 18) for use in adult patients with known or suspected coronary artery disease (CAD) to evaluate myocardial ischemia and infarction. This approval is significant as CAD affects over 18 million adults in the U.S. and is the leading cause of death in the country.
Flyrcado is a cyclotron-produced radioactive diagnostic drug used in positron emission tomography (PET) myocardial perfusion imaging (MPI) and is administered via intravenous injection. The drug's efficacy and safety were assessed in two clinical studies involving patients with suspected or known CAD, demonstrating sensitivity ranging from 63% to 89% and specificity from 53% to 86% for detecting significant CAD.
Common adverse reactions noted in participants included dyspnea, headache, and chest pain, among others. The approval of Flyrcado is expected to enhance diagnostic capabilities for CAD, potentially impacting treatment strategies and patient outcomes on a global scale.
Source: FDA.gov