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The U.S. Food and Drug Administration announced today that it has approved Vizamyl, a drug manufactured for General Electric Healthcare (NYSE: GE ) by Medi-Physics that is used in brain imaging to detect Alzheimer's disease and dementia.
Dementia caused by Alzheimer's has been associated with the buildup of an abnormal protein known as beta amyloid and also the damage or death of brain cells. The drug Vizamyl attaches to that protein and is then detected in a 3D PET-scan, which helps doctors evaluate whether the dementia is likely caused by Alzheimer's.
While the detection of beta amyloid by Vizamyl will not necessarily mean that the dementia is caused by Alzheimer's, its lack of detection largely rules out the disease. The release did note "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 [Alzheimer's disease] or other 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 [Alzheimer's disease] and dementia."
Vizamyl is the second drug of its kind -- the FDA first approved Amyvid made by Eli Lilly & Co. However, in September of this year the Centers for Medicare & Medicaid Services denied patient access to Amyvid and a Wall Street Journal story noted a CMMS advisory panel "in January said there was insufficient evidence that the PET procedure with Amyvid can improve health outcomes."
The FDA added that the effectiveness of Vizamyl was established through two studies with 761 total participants, adding that it "correctly detects beta amyloid in the brain" and "trained readers can accurately interpret the scans."