FDA Approves GE HealthCare’s Flyrcado for Diagnosing Coronary Artery Disease

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The FDA has approved GE HealthCare’s Flyrcado (flurpiridaz F 18) injection, a novel emission tomography (PET) myocardial perfusion imaging (MPI) agent for diagnosing coronary artery disease (CAD). According to the company, Flyrcado offers improved diagnostic accuracy over traditional single-photon emission computed tomography (SPECT) MPI, which is commonly used in nuclear cardiology. Additionally, Flyrcado has a half-life of 109 minutes, which is much longer than other PET MPI tracers.¹

“Flyrcado is the most exciting development in the field of nuclear cardiology over the past few decades. Although PET MPI as a modality enables high diagnostic accuracy as compared to SPECT MPI, only a minority of annual PET scans in the US are PET MPI because of limited access to the currently available PET tracers—which may be addressed with the introduction of Flyrcado. I am excited for this new radiotracer and its potential impact, as a game changer, for diagnosing the disease with the highest mortality rate in the world,” said Flyrcado clinical trials principal investigator Jamshid Maddahi, MD, FACC, MASNC, clinical professor of medicine and molecular and medical pharmacology, UCLA School of Medicine, director, Biomedical Imaging Institute, in a press release.

The regulatory action was based on findings from the AURORA Phase III trial, in which Flyrcado was compared with both invasive coronary angiography as a standard of truth to determine diagnostic efficacy in detecting CAD, as well as with SPECT MPI. Results found that Flyrcado demonstrated superior efficacy compared to SPECT and was validated against coronary angiography. Common adverse events included dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.¹

“Given the desirable properties of flurpiridaz F 18, both in terms of myocardial uptake and fluorine-18 imaging characteristics, Flyrcado represents a favorable combination of imaging agent pharmacology and convenience to imaging institutions and patients. There are new frontiers for cardiac PET that this tracer can achieve; it can be ordered as a unit dose, and it offers the flexibility to perform exercise stress testing. We expect new imaging centers to be able to offer cardiac PET to their patients, making it more convenient to access PET MPI and providing a meaningful impact for clinicians and their patients,” said Mouaz Al-Mallah, MD, MSc, MASNC, immediate past president, American Society of Nuclear Cardiology, director, Cardiac PET, Houtson Methodist Hospital, in the press release.

According to the Centers for Disease Control and Prevention, CAD is the most common form of heart disease, accounting for 371,506 deaths in the United States in 2022. An estimated one out of every 20 adults over 20 years of age in the United States have CAD. Heart disease as a whole is considered the leading cause of death in the United States for men, women, and people of most racial and ethnic groups. Also in 2022, 702,880 people died from heart disease, equal to one in every five people.²

“As the first and only FDA-approved F 18 PET MPI radiotracer for CAD detection, Flyrcado can make a real difference to clinicians and their patients. This is another example of GE HealthCare’s commitment to innovating and investing to shape the future of molecular imaging, increasing diagnostic confidence and addressing unmet patient needs,” said Kevin O’Neill, CEO, Pharmaceutical Diagnostics (PDx) segment, GE HealthCare, in the press release.

Flyrcado is expected to launch in the United States early next year.¹

References

1. GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease. Business Wire. September 27, 2024. Accessed September 30, 2024. https://www.businesswire.com/news/home/20240927874133/en

2. Heart Disease Facts. CDC. Accessed September 30, 2024. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html