Eli Lilly and Company announced that the FDA has approved Amyvid (florbetapir F 18 injection), an adjunct 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 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.
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. Results of the first study showed measurements of postmortem cortical amyloid burden correlated with median Amyvid scores. In the second study, Amyvid PET showed 96% sensitivity and 100% specificity in patients who received an Amyvid PET scan within one year of death.
For more information call (800) 545-5979 or visit www.amyvid.com.