FDA Approves PET Imaging Agent for Alzheimer’s Evaluation

The FDA has approved florbetapir, a radioactive diagnostic agent for use with PET imaging, for the evaluation of Alzheimer’s disease, according to developer Eli Lilly.

The agent, brand name Amyvid, is indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s and other causes. Amyvid binds to amyloid plaques, considered a key player in Alzheimer’s disease, and is detected in PET scans.

Amyvid is the first and only FDA-approved radioactive diagnostic agent for brain imaging of amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s or other causes, according to Daniel Skovronsky, MD, PhD, president and CEO of Lilly subsidiary Avid, and global brand development leader for Amyvid at Lilly, speaking during a telephone media briefing.

A scan showing few or no amyloid plaques would mean a reduced likelihood the impairment is due to Alzheimer’s and can help rule out the disease.  A positive scan showing moderate to frequent amyloid plaques is present in people with Alzheimer’s, as well as patient with other neurologic conditions and normal aging.

A florbetapir scan will be combined with other clinical information from referring physician, noted Edward Coleman, MD, professor of radiology at Duke University Medical Center, also speaking during the briefing.

“This approval marks a great advancement in nuclear medicine practice as it enables us to evaluate the presence or absence of moderate to frequent levels of amyloid plaques in a patient’s brain,” he said. “In conjunction with other tests, florbetapir may help give physicians additional information in evaluating patients for the cause of their cognitive decline.”

Last year, the FDA expressed concerns about radiologists’ ability to consistently read the scans, Skovronsky noted. The company has developed an online and in-person reader training program, and the images should be interpreted only by those who have completed training.