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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

Sat, 04/07/2012 - 3:36am
Bio-Medicine.Org

INDIANAPOLIS, April 6, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced the U.S. Food and Drug Administration (FDA) approval of Amyvid™, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.[1] Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer's Disease,[2],[3],[4] and is detected using PET scan images of the brain.[1]

A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.[2] [5] A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.[1], [4], [6]

It's important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease, or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.[1]

Alzheimer's Disease is one of several possible causes of cognitive decline. Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms including memory, visuospatial ability, executive function, behavior and language deficiencies.[4],[7] Because a definitive diagnosis of Alzheimer's Disease is usually determined u

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