Alzheimer’s diagnostic comes with caveats
pharmafile | April 10, 2012 | News story | Sales and Marketing | Alzheimer's, Amyvid, lilly
A first-in-class test for Alzheimer’s disease has been approved by the FDA, but its makers have stressed its limitations.
Lilly’s Amyvid is a radioactive diagnostic agent which will be used for brain imaging of beta-amyloid plaques in patients with suspected Alzheimer’s Disease.
The pharmaceutical company acquired Avid Radiopharmaceuticals and Amyvid for $800 million in 2010 to complement its pipeline Alzheimer’s treatments, but has had trouble gaining FDA approval for the diagnostic until now.
The US regulator has now approved the diagnostic, but its makers must ensure that test readers are trained in how to use the test, as it remains open to misinterpretation.
Amyvid binds to amyloid plaques, a hallmark of Alzheimer’s and is detected using PET scan images of the brain, but it remains impossible to be certain that a patient with raised levels of the plaques has Alzheimer’s.
For that reason Lilly says the test should only be used to suggest a negative diagnosis –i.e. where patients have low levels of amyloid plaques, their cognitive decline is probably not due to Alzheimer’s.
“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 chief executive 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.”
Despite these limitations, the test is nevertheless a step forward in diagnosing the disease, which is often advanced before patients are asked to take a standard mental reasoning test.
Edward Coleman, M.D., professor of radiology, Duke University Medical Center. “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.
In conjunction with other tests, florbetapir may help give physicians additional information when evaluating patients for the cause of their cognitive decline.”
For Lilly, the decisive moment comes later this year, when data from its phase III Alzheimer’s drug treatment solanezumab is released.
A string of failures in the field means analysts and observers are not optimistic about the drug’s chances, but if the drug demonstrates even limited efficacy, it could still be a commercially viable treatment.
Andrew McConaghie
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