Vizamyl approved by FDA to aid dementia diagnosis

The FDA today cleared a new PET amyloid imaging agent—F-18 flutemetamol (Vizamyl). The addition of Vizamyl provides more options for dementia experts evaluating amyloid in the brain to rule out Alzheimer’s and other neurodegenerative disease.

Vizamyl now joins Amyvid as the currently FDA approved diagnostic PET agents for amyloid imaging. The new agent can be used to evaluate amyloid burden and distinguish between brain disorders like Alzheimer’s and frontotemporal dementia, which have similar cognitive symptoms. 

“Many Americans are evaluated every year to determine the cause of diminishing neurologic functions, such as memory and judgment, that raise the possibility of Alzheimer’s disease,” said Shaw Chen, MD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research in a release. “Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD [Alzheimer’s] and dementia.”

GE Healthcare’s applications for both FDA and European regulatory clearance were approved earlier this year. Eli Lilly currently produces Amyvid for commercial use. Still other amyloid PET agents, including Navidea’s F-18 NAV4694, are on the research bench and have yet to be approved.

For more on this topic, please read GE submits amyloid imaging agent for review in the U.S., Europe.