Monday, October 28, 2013

FDA Approves Imaging Drug to Evaluate Alzheimer’s and Dementia

On Friday, the Food and Drug Administration (FDA) approved Vizamyl (flutemetamol) for use with positron emission tomography (PET) brain imaging in adults being evaluated for Alzheimer's disease (AD) and dementia. The approval was the FDA's second approval for a radioactive diagnostic drug used to detect images of beta-amyloid—a major mechanism in progression of AD. Amyvid was the first such drug approved. 

The effectiveness of Vizamyl was measured by two clinical trials with a total of 384 participants with varying degrees of cognitive function. All patients were injected with the drug and underwent PET imaging. Results showed that Vizamyl accurately detected beta-amyloid in the brain. In addition, the study confirmed that the scans were reproducible and could be interpreted accurately by trained readers. 

The safety of the radioactive drug was further established in 761 participants. Safety risk included hypersensitivity reactions and radiation exposure. Common side effects included flushing, headache, increased blood pressure, nausea, and dizziness.

Sandra Jacobson, M.D., an associate research professor at the University of Arizona College of Medicine, told Psychiatric News that "Flutemetamol is like florbetapir [Amyvid] and other compounds in the pipeline. The question now comes down to whether flutemetamol is superior to florbetapir. CMS asked for more evidence regarding florbetapir’s utility before further consideration of Medicare coverage. Will the same hold true for flutemetamol? At this point, it is too early to tell." Jacobson concluded that this FDA approval is an advancement for AD research and clinical work.

To read about other techniques used to evaluate AD and dementia, see the Psychiatric News article, "Lab Testing in Diagnosis of Alzheimer’s Disease: An Update."

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