Eli Lilly and Co. probably will get approval for its newly acquired imaging agent used to diagnose Alzheimer’s disease, but so far analysts are unimpressed.
On Jan. 20, an advisory panel of outside experts told the U.S. Food and Drug Administration that Lilly’s florbetapir should be approved—if Lilly develops and implements a training program to help train medical professionals to read the brain scans that the agent helps produce.
Indianapolis-based Lilly still has to develop such a program, delaying approval of florbetapir. But the unanimous OK from the panel, whose advice the FDA usually follows, is an encouraging sign.
Florbetapir, which Lilly has dubbed Amyvid, binds to the plaques of beta-amyloid proteins found in the brains of Alzheimer’s patients, dyeing them so they show up on a PET scan. If scans of a florbetapir-dyed brain show nothing, a doctor can rule out Alzheimer’s. If they show a plaque, then a doctor knows to proceed to try to pin down the reason for a patient’s dementia.
The trouble for Lilly, noted stock analysts writing on the Seeking Alpha website, is that even if florbetapir helps doctors diagnose Alzheimer’s patients more quickly and more accurately, there are still no treatment options that reverse the effects of Alzheimer’s. Lilly has one Alzheimer’s drug in late-stage testing, but it had to halt testing of a second drug last year after it actually worsened the disease in patients.
After the FDA panel supported the imaging agent, Lilly's stock price hardly budged, closing that day at $34.75 per share.
Florbetapir’s main use would be to help doctors in clinical trials of experimental Alzheimer’s medicines to more clearly identify patients suffering from the disease—as opposed to other kinds of dementia. Currently, such diagnoses are done by psychiatrists interviewing patients and making a judgment call, not by any quantifiable test of blood or body fluids.
The limited market may explain, according to the Seeking Alpha analysts, why Wall Street isn't giving Lilly much credit for florbetapir in its revenue projections.
But many medical professionals are excited to have an imaging test to firm up their diagnoses of patients with dementia.
“Physicians currently have little confidence in their ability to determine the cause of dementia, and as a result they often don’t even try,” Dr. Norman Foster, a neurologist at the University of Utah, told the FDA panel, according to The New York Times. As a result, he said, families are left in limbo, unable to plan for the future if it is Alzheimer’s and delaying treatment if it is not.
“The preventable costs are enormous,” Foster added. “The emotional toll is incalculable.”