The FDA has approved Amyvid, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques associated with Alzheimer’s Disease and other cognitive decline, according to Eli Lilly and Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly.

“It's estimated that one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not end up having Alzheimer's Disease pathology upon autopsy," said Daniel Skovronsky, M.D., Ph.D., president and CEO of Avid, and global brand development leader for Amyvid at Lilly. "The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients.”

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.

Because Amyvid loses over half of its radioactivity every two hours, Amyvid must be distributed directly from a radiopharmacy to the imaging centers where it will be administered within several hours. Beginning in June, a limited number of radiopharmacies will be distributing Amyvid with the goal of making the product available in more areas as soon as possible.

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.

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.