FDA Approves Multiple New Indications for the Brain PET Imaging Agent Vizamyl

The Food and Drug Administration (FDA) has approved multiple new indications for use of the flutemetamol F18 injection in brain positron emission tomography (PET) imaging.

The new indications for flutemetamol F18 injection (Vizamyl, GE HealthCare) include amyloid quantification, monitoring of anti-amyloid therapies, predicting dementia and other cognitive decline due to Alzheimer’s disease (AD), and diagnosing AD, according to GE HealthCare, the manufacturer of Vizamyl.

While flutemetamol F18 injection was previously approved in 2013 for visual estimation of amyloid neuritic plaque density in adults with cognitive impairment, GE HealthCare said the indication for amyloid quantification facilitates a more objective assessment that goes hand in hand with the new indication for monitoring the effectiveness of anti-amyloid modalities.

“The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,” noted Phillip Kuo, M.D., Ph.D, FACR, a professor of radiology, section chief of nuclear medicine and director of theranostics at the City of Hope National Medical Center in Duarte, Calif. “Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued.”

GE HealthCare noted that updated criteria from the Alzheimer’s Association in support of AD diagnosis based on an abnormal amyloid PET findings facilitated the AD diagnosis indication for flutemetamol F18 injection.