US FDA Approves GE Healthcare s Diagnostic Drug for Heart Disease

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. (REUTERS/Andrew Kelly)

(Reuters) - The U.S. Food and Drug Administration approved GE HealthCare's diagnostic drug for use in detection of coronary artery disease, the company said on Friday.

Flyrcado, which is a radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging (MPI), will be available in some U.S. markets in early 2025 before being expanded.

PET-MPI is a non-invasive imaging test which uses a type of nuclear medicine called radioactive tracers to asses how well blood flows to the muscle of the heart. The 3D images of the tracer's distribution can then be produced.

The company said Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand access to PET-MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index and women.

Doctors have underscored Flyrcado's distinct clinical benefits such as higher-quality imaging, greater defect resolution and improved workflow, brokerage Stifel said in a note ahead of the approval.

Use of Flyrcado helped accurately classify 74% to 89% of participant scans in a study.

GE HealthCare said Flyrcado delivers higher diagnostic efficacy in patients with known or suspected CAD, compared to SPECT MPI which is the predominant procedure currently being used.

CAD is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It impacts over 18 million adults in the U.S., and is the leading cause of death in the country, according to the FDA.

Flyrcado decays ten times slower than currently approved cardiac PET radiotracers, GE HealthCare said, which can help combine exercise stress testing with imaging.

The company also has similar products for detection of breast cancer and Alzheimer's disease.

Stifel analysts estimate approval of Flyrcado could add about 0.3% to 0.6% of sales growth for the company in the medium to long term.

 

(Reporting by Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri)