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FDA approves Vizamyl for Alzheimer's disease, dementia evaluation

The radioactive diagnostic drug flutemetamol F 18 injection has received FDA approval for use with positron emission tomography in patients being evaluated for Alzheimer's disease or dementia, according to an agency press release.

Flutemetamol F 18 injection (Vizamyl, Medi-Physics Inc.) is used with PET to detect beta-amyloid in the brain. Using the newly approved drug could help rule out Alzheimer's disease as the cause of dementia — a negative scan signals little or no beta-amyloid accumulation in the brain, demonstrating the cause of the dementia is probably not due to Alzheimer's disease, according to the press release. A positive scan, however, points to the possibility of a moderate or greater amount of amyloid in the brain, although it does not ascertain 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,” Shaw Chen, MD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for [Alzheimer’s disease] and dementia.” 

Flutemetamol F 18 injection is the second diagnostic drug approved to visualize beta-amyloid on a PET scan of the brain, according to the press release. The first — florbetapir F 18 injection (Amyvid, Avid Radiopharmaceuticals) — was approved in 2012 to aid in the evaluation of Alzheimer's disease and other causes of cognitive decline in adults.

Approval is based on two clinical trials of 384 participants with a range of cognitive function who were injected with flutemetamol F 18 and received a PET scan. The images were interpreted by five independent readers masked to all clinical information, and some of the scan results were confirmed by autopsy, according to the press release.

The trials confirmed Vizamyl's ability to correctly detect beta-amyloid in the brain and that the scans are reproducible and trained readers can accurately interpret the results.

The drug is not indicated to predict the development of Alzheimer's disease or to determine whether patients respond to treatment for the disease. PET images using the drug should be interpreted by health care professionals who completed training in an image interpretation program, according to the FDA, and the drug label includes information about image interpretation.

Hypersensitivity reactions and the risks associated with image misinterpretation and radiation exposure exist with the newly approved drug, and common adverse effects include flushing, headache, increased blood pressure, nausea and dizziness.