GE HealthCare has secured the FDA’s approval for an injectable, radioactive imaging agent that gives clinicians a clearer picture into blocked arteries in the heart and any damage to cardiac tissue.
The company described Flyrcado (flurpiridaz) as a first-of-its-kind imaging tracer, for PET scans that help assess the perfusion of heart muscle cells. It relies on the radioisotope fluorine-18, the same unstable element used to help diagnose breast cancer and Alzheimer’s disease.
With an extended half-life of nearly two hours—more than 10 times that of some other cardiac diagnostic agents—that extra time allows clinicians to put patients on a treadmill for exercise stress testing and track blood flow in cases of coronary artery disease as well as re-scan the patient during the same session if needed.
Flyrcado can also be manufactured and shipped from an off-site pharmacy, according to GE HealthCare, which also touted the improvements in diagnostic efficiency seen with PET scans compared to the more common approach of single-photon emission computed tomography, or SPECT. The company estimates that about 6 million myocardial perfusion imaging, or MPI, procedures are conducted in the U.S. each year.
GE HealthCare has been developing flurpiridaz F18 since it bought up the global rights from radiopharmaceutical developer Lantheus, with a $5 million down payment in 2017. The two companies will also collaborate on its commercialization, with an initial U.S. rollout scheduled for early next year, and Lantheus is set to receive up to $60 million in milestone payments plus royalties.
A previous clinical trial—comparing scans from patients with coronary artery disease who underwent both PET and SPECT imaging, followed by invasive angiography—demonstrated an increase in diagnostic sensitivity with flurpiridaz, at 80.3% versus 68.7%, while specificity remained similar.
The study also showed that flurpiridaz PET scans performed better in detecting the size and severity of infarctions as well as in overall image quality and radiation exposure. The results were published last year in the Journal of the American College of Cardiology.
Elsewhere in GE HealthCare’s pharmaceutical diagnostics segment, fluorine-18 is used as a PET tracer in Cerianna (fluoroestradiol), for highlighting estrogen receptor-positive tumors alongside biopsies in patients with metastatic or recurrent breast cancer, and in Vizamyl (flutemetamol) for estimating the density of beta amyloid plaques in the brain.