FDA approves GE Healthcare’s brain-imaging drug

GE Healthcare's radioactive diagnostic drug, Vizamyl, has been approved by the US Food and Drug Administration (FDA). Vizamyl (flutemetamol F 18 injection) has been approved for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.

This is the second diagnostic drug available for visualising beta amyloid on a PET scan of the brain. In 2012, the FDA approved Amyvid (Florbetapir F 18 injection) to help evaluate adults for AD and other causes of cognitive decline.

Dementia caused by Alzheimer's disease is associated with the accumulation in the brain of an abnormal protein called beta amyloid. 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. Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD and dementia."

Shaw Chen, M.D., deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research.

Vizamyl's approval was based on its effectiveness that was found in two clinical trials comprised of 384 participants with a range of cognitive function. The study results also demonstrate that Vizamyl correctly detects beta amyloid in the brain.