The FDA has approved Vizamyl (flutemetamol F 18; GE Healthcare) injection, for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl is currently the only PET imaging tracer available that provides brain scans in color rather than in black and white.
Vizamyl is a radioactive diagnostic agent that works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid.
A negative scan indicates there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to Alzheimer’s disease. A positive scan indicates there is probably a moderate or greater amount of amyloid in the brain.
However, this does not establish a diagnosis of Alzheimer’s disease or other dementia. While the approval of Vizamyl provides another tool for physicians to evaluate patients with cognitive decline, it does not replace other diagnostic tests used in evaluating Alzheimer’s disease and dementia.
The effectiveness of Vizamyl was established in two studies comprised of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and were scanned. Five independent readers then interpreted the images.
The results demonstrated that Vizamyl correctly detected beta amyloid in the brain, and that the scans were reproducible where trained readers could accurately interpret the scans.
Vizamyl is the second brain imaging drug approved by the FDA to evaluate patients for Alzheimer’s disease and dementia. In 2012, the FDA approved Amyvid (florbetapir F 18; Eli Lilly) injection to aid in the evaluation of adults for Alzheimer’s disease and other causes of cognitive decline.
Vizamyl will be commercially available in 2014.
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