Alzheimer's, Dementia & Mental Health
Drug that May Suggest You Don't Have Alzheimer's
Okayed by FDA for Use with PET Scan
Vizamyl helps determine how much beta amyloid, if
any, in your brain and provide some idea if it is Alzheimer's or other
Oct. 25, 2013 - The U.S. Food and Drug
Administration today approved Vizamyl (flutemetamol F 18 injection), a
radioactive diagnostic drug for use with positron emission tomography
(PET) imaging of the brain in adults being evaluated for Alzheimer's
disease (AD) and dementia. The drug, for use only by by professionals,
helps determine if the amount of beta amyloid in the patient's brain
suggests Alzheimer's disease or some other dementia.
Dementia is associated with diminishing brain
functions such as memory, judgment, language and complex motor skills.
The dementia caused by AD is associated with the accumulation in the
brain of an abnormal protein called beta amyloid and damage or death of
brain cells. However, beta amyloid can also be found in the brain of
patients with other dementias and in elderly people without neurologic
Vizamyl 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 Vizamyl scan means that there is little or
no beta amyloid accumulation in the brain and the cause of the dementia
is probably not due to AD.
A positive scan means that there is probably a
moderate or greater amount of amyloid in the brain, but it does not
establish a diagnosis of AD or other dementia. Vizamyl does not replace
other diagnostic tests used in the evaluation of AD and dementia.
“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, M.D., deputy director of the Office of Drug Evaluation IV in
the FDA’s Center for Drug Evaluation and Research.
“Imaging drugs like Vizamyl provide physicians with
important tools to help evaluate patients for AD and dementia.”
Vizamyl is the second diagnostic drug available for
visualizing beta amyloid on a PET scan of the brain. In 2012, FDA
approved Amyvid (Florbetapir F 18 injection) to help evaluate adults for
AD and other causes of cognitive decline.
Vizamyl’s effectiveness was established in two
clinical studies comprised of 384 participants with a range of cognitive
function. All participants were injected with Vizamyl and were scanned.
The images were interpreted by five independent readers masked to all
clinical information. A portion of scan results were also confirmed by
The study results demonstrate that Vizamyl
correctly detects beta amyloid in the brain. The results also confirm
that the scans are reproducible and trained readers can accurately
interpret the scans. Vizamyl’s safety was established in a total of 761
Vizamyl is not indicated to predict the development
of AD or to check how patients respond to treatment for AD. Vizamyl PET
images should be interpreted only by health care professionals who
successfully complete training in an image interpretation program. The
Vizamyl drug labeling includes information about image interpretation.
Safety risks associated with Vizamyl include
hypersensitivity reactions and the risks associated with image
misinterpretation and radiation exposure. Common side effects associated
with Vizamyl include flushing, headache, increased blood pressure,
nausea and dizziness.
Vizamyl is manufactured for GE Healthcare by Medi-Physics,
Inc., based in Arlington Heights, Ill.
For more information:
FDA Approved Drugs: Questions and Answers
FDA: Drug Innovation
The FDA, an agency within the U.S. Department of
Health and Human Services, protects the public health by assuring the
safety, effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and medical
devices. The agency also is responsible for the safety and security of
our nation’s food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco products.
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