Eli Lilly & Co. and Avid Radiopharmaceuticals, Inc. announced they received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending approval of Amyvid (Florbetapir F 18) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. The positive opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the European Union (EU). The Commission usually decides on CHMP recommendations within three months. Amyvid for intravenous use was approved by the U.S. Food and Drug Administration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18. Amyvid is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in 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 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. 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.

Eli Lilly & Co. and Avid Radiopharmaceuticals, Inc. 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. Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer's Disease and is detected using PET scan images of the brain. 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. 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. 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. 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. Because a definitive diagnosis of Alzheimer's Disease is usually determined upon autopsy, physicians rely on medical history, clinical examination and a variety of diagnostic tools when evaluating patients. Amyvid was evaluated in three clinical studies that examined images from healthy adult patients as well as patients with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program.