FDA Approves Second Brain Imaging Drug to Help Evaluate Dementia

The FDA approved a new radioactive diagnostic drug for use with positron emission tomography imaging of the brain in adults being evaluated for Alzheimer's disease and dementia.

The FDA approved a new radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease and dementia. Vizamyl (Flutemetamol F18 injection) works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid.

Beta amyloid, the abnormal protein that accumulates in the brain and is associated with Alzheimer’s disease, can also be found the brains of patients with other types of dementia and in elderly people without a neurologic disease.

A negative Vizamyl scan indicates that 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 Vizamyl scan suggests that there is probably a moderate or greater amount of amyloid in the brain, but that does not establish a diagnosis of Alzheimer’s disease or other dementia.

According to the FDA, Vizamyl does not replace other diagnostic tests used to evaluate Alzheimer’s disease and dementia. It is not indicated to predict the development of Alzheimer’s disease or to check how patients respond to treatments for the disease.

Safety risks associated with Vizamyl include hypersensitivity reactions and the risks associated with image misinterpretation and radiation exposure. Common side effects include flushing, headache, increased blood pressure, nausea and dizziness.

Medi-Physics, Inc., produces Vizamyl for GE Healthcare.