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FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Date:4/6/2012

rson reader training program for physicians using Amyvid. Errors may occur in the estimation of plaque density during image interpretation.

About Amyvid
Amyvid is a radioactive diagnostic agent tagged with a radioisotope called fluorine-18. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. Amyvid produces a positron signal, which is detected by a PET scanner and used to create a brain image. A radiologist, who should have successfully completed Amyvid reader training, then interprets the image to evaluate for the presence or absence of significant amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain. This information is reported back to the referring physician, who then determines the next steps in the evaluation and management of the patient.

Indication and Important Safety Information About Amyvid

Indication
Amyvid is a radioactive diagnostic agent for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's Disease at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Limitations of Use:
A positive Amyvid scan does not establish a diagnosis
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SOURCE Eli Lilly and Company
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