A Food and Drug Administration advisory panel voted unanimously to approve a new Alzheimer’s screening dye, pending future studies of whether physicians trained on the test can properly interpret the results.
The 16-0 vote offers a significant vote of confidence for Eli Lilly’s chemical imaging drug, known as Amyvid, which, after being injected into patients, highlights the brain plaque that is associated with Alzheimer’s. Today, Alzheimer’s diagnoses are made through observation of suspected sufferers, which is a slower, less reliable process, and it takes an autopsy to make a conclusive assessment.
But the same panel voted 13-3 to reject the approval of Amyvid absent the further research. Panelists expressed concern about the potential for widely varying interpretations by different doctors of the results of scans that use Amyvid.
The FDA isn’t required to adhere to the recommendations of advisory panels, but it ordinarily does.
Dr. Daniel M. Skovronsky, CEO of the Lilly subsidiary that developed Amyvid, Avid Radiopharmaceuticals, said he didn’t expect the further studies to be a significant impediment.
“We don’t know exactly what FDA will want,” Dr. Skovronsky told The New York Times. “But it should take months to generate this type of data, not years.”
Alzheimer’s, a terminal, incurable disease that provokes dementia and the loss of basic body function in its elderly victims, afflicts roughly 5 million Americans. The figure is expected to rise in coming years, with the aging of the Baby Boomer generation.
While brain scans won’t reverse or even slow the onset of Alzheimer’s, advocates say that the procedure will help victims and their families prepare for the future.


