GE HealthCare has received approval from the US Food and Drug Administration (FDA) for its Flyrcado (flurpiridaz F 18) injection, a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent to detect coronary artery disease (CAD).
Flyrcado is designed for patients with known or suspected CAD, providing a ready-to-use unit dose that can be manufactured offsite.
It is expected to improve access to PET MPI, particularly for patients who are challenging to image, such as those with a high BMI and women.
The efficacy of Flyrcado was demonstrated in the international AURORA Phase III trial, where it was compared with invasive coronary angiography and SPECT MPI.
GE HealthCare pharmaceutical diagnostics (PDx) segment CEO Kevin O’Neill said: “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.”
Flyrcado joins GE HealthCare's portfolio of FDA-approved molecular imaging PET products, which includes Cerianna for detecting estrogen receptor-positive lesions in breast cancer patients and Vizamyl for estimating beta-amyloid plaque density in adults with cognitive decline.
In 2017, the company acquired exclusive worldwide commercialisation rights for flurpiridaz F 18 from Lantheus, leading the product's development to approval.
Lantheus will collaborate on Flyrcado's commercialisation and receive royalties based on sales milestones.
Flyrcado is expected to be available in initial US markets in early 2025, with wider availability to follow.
In July 2024, GE HealthCare announced that it is partnering with Amazon Web Services to develop AI models that can analyse complex medical data.
