US FDA Approves GE HealthCare’s Diagnostic Drug for Heart Disease, According to Reuters

The U.S. Food and Drug Administration has granted approval to GE HealthCare for its diagnostic drug aimed at detecting coronary artery disease, the company announced on Friday.

The drug, named Flyrcado, serves as a radioactive diagnostic agent for positron emission tomography (PET) myocardial perfusion imaging (MPI) and is set to become available in select U.S. markets by early 2025, with plans for broader distribution thereafter.

PET-MPI is a non-invasive imaging procedure that employs radioactive tracers to evaluate blood flow to the heart muscle. This method generates 3D images showing the distribution of the tracer.

According to GE HealthCare, Flyrcado can be produced in an offsite pharmacy and shipped as a ready-to-use single dose, which may enhance access to PET-MPI and improve diagnostic precision, particularly for challenging patient demographics, including those with a higher body mass index and women.

Healthcare professionals have highlighted the clinical advantages of Flyrcado, such as superior image quality, better defect resolution, and streamlined workflow, as noted by brokerage firm Stifel prior to the drug’s approval.

In clinical studies, the use of Flyrcado accurately classified between 74% and 89% of the scans of participants. The company asserts that Flyrcado offers improved diagnostic effectiveness for patients with known or suspected coronary artery disease when compared to the currently dominant SPECT MPI procedure.

Coronary artery disease involves the narrowing or blockage of coronary arteries, which are responsible for delivering oxygen-rich blood to the heart. This condition affects over 18 million adults in the United States and is the leading cause of death in the country, as reported by the FDA.

Flyrcado’s decay rate is ten times slower than other approved cardiac PET radiotracers, potentially facilitating the integration of exercise stress tests with imaging procedures.

GE HealthCare also offers similar diagnostic products for breast cancer and Alzheimer’s disease.

Analysts from Stifel estimate that the approval of Flyrcado could contribute approximately 0.3% to 0.6% to the company’s sales growth in the medium to long term.