Summary: The FDA has approved flurpiridaz F-18 (Flyrcado) as the first PET imaging agent for coronary artery disease, offering improved diagnostic accuracy and broader distribution.

Key Takeaways

  1. The FDA has approved flurpiridaz F-18 (Flyrcado) as the first PET imaging agent for adults with coronary artery disease (CAD), offering enhanced diagnostic accuracy.
  2. Flurpiridaz F-18 has a longer half-life, enabling broader distribution and improved myocardial perfusion imaging (MPI) for difficult-to-image patients, such as those with high BMI and women.
  3. Clinical trials demonstrated the drug’s sensitivity (74%-89%) and specificity (53%-70%) in detecting CAD, with U.S. market launch planned for early 2025.

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The U.S. FDA has approved flurpiridaz F-18 (Flyrcado; GE Healthcare), the first PET imaging agent for adults with known or suspected coronary artery disease (CAD). CAD, the leading cause of death in the U.S., occurs when coronary arteries narrow or become blocked, reducing blood flow to the heart and potentially leading to myocardial ischemia and heart attacks.

Effectiveness of Flurpiridaz F-18 for CAD

Flurpiridaz F-18 is a nuclear medicine tracer used in myocardial perfusion imaging (MPI) to assess blood flow to the heart muscle at rest and during stress. Administered intravenously, it offers improved diagnostic accuracy over the current SPECT MPI standard. Its longer half-life of 109 minutes allows broader distribution than other PET cardiac tracers.

The drug’s safety and efficacy were validated in two large clinical trials, showing a sensitivity of 74-89% and specificity of 53-70% for detecting significant CAD. The trials demonstrated its diagnostic potential, especially in hard-to-image patients, such as those with high BMI and women, where traditional imaging may be less accurate.

Advancing Cardiac Imaging for Difficult Patients

“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,” says 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 launch Flyrcado in U.S. markets in early 2025, with expanding availability thereafter.