Flutemetamol F 18 Approved for PET Scan in Dementia Evaluation
FDA today announced the approval of flutemetamol F 18 injection for positron emission tomography (PET) imaging in adults as part of an evaluation for Alzheimer's disease and dementia.
The imaging agent will be sold as Vizamyl by GE Healthcare. Labeling for the product is not yet available, and the company has not announced a product launch date.
According to FDA, flutemetamol F 18 attaches to Β-amyloid plaques in the brain, allowing them to be visualized in a PET scan. Β-amyloid plaques are associated with Alzheimer's disease, but the precise relationship between the two is unclear.
FDA stated that a negative flutemetamol F 18 PET scan result indicates that the patient's cognitive decline is probably not caused by Alzheimer's disease. A positive scan result indicates the presence of at least a moderate amount of Β-amyloid plaques but does not establish a diagnosis of Alzheimer's disease or other dementia.
Flutemetamol F 18 should not be used to assess a patient's response to Alzheimer's disease treatment or to predict the likelihood that Alzheimer's disease will develop in a patient, according to the agency.
Common adverse events associated with flutemetamol F 18 in clinical trials included flushing, headache, increased blood pressure, nausea, and dizziness. Hypersensitivity reactions may also occur in patients who receive the imaging agent, FDA stated.