Eli Lilly and Company (LLY) on Friday said the Food and Drug Administration (FDA) has approved Amyvid, a radioactive diagnostic agent for use in patients being evaluated for Alzheimer's Disease and other causes of cognitive decline.
Amyvid or florbetapir F 18 injection is a molecular imaging agent under investigation for the Positron Emission Tomography imaging of beta-amyloid plaque in the brains of Alzheimer's disease patients.
A negative Amyvid scan indicates sparse-to-no amyloid plaques are 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.
A positive 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.
Amyvid was a lead candidate of Avid Radiopharmaceuticals, which became a wholly owned subsidiary of Lilly through its acquisition by the Indianapolis, Indiana-based health care giant in December 2010.
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