EU nod for Lilly brain diagnostic
pharmafile | January 18, 2013 | News story | Research and Development, Sales and Marketing | Alzhheimer's, Amyvid, brain, lilly
Eli Lilly’s diagnostic radiopharmaceutical Amyvid has been approved in Europe to assess whether patients have Alzheimer’s disease.
Amyvid (Florbetapir F 18 Injection), developed by Lilly subsidiary Avid Radiopharmaceuticals, is indicated for PET imaging of beta-amyloid neuritic plaque density in patients’ brains.
The FDA approved the test, which is injected into the bloodstream, last year and the idea is that it should be used in adults with cognitive impairment who are being evaluated for Alzheimer’s or other potential causes.
Amyloid beta is the main ingredient of brain plaques found in Alzheimer’s patients.
“We believe that Amyvid fills an unmet need in the medical community, providing physicians with important information about the presence or absence of beta-amyloid plaques that can help identify the cause of their patients’ cognitive symptoms,” said Diane Bakaysa, Amyvid global brand development leader.
However, the product comes with caveats: a positive Amyvid scan does not establish a diagnosis of Alzheimer’s or other cognitive disorder.
In other words, it is still impossible to be certain that a patient with raised levels of the plaques has Alzheimer’s.
This means that the test should only be used to suggest a negative diagnosis – or, put another way, where patients have low levels of amyloid plaques, their cognitive decline is probably not due to Alzheimer’s.
Even establishing this means doctors will be able to avoid unnecessary or even harmful treatments associated with a misdiagnosis, Bakaysa added.
Anyone reading Amyvid PET scans should complete a training programme beforehand, Lilly insists, and it should only be used alongside a clinical evaluaton.
It is a mark of the fact that any advance – however small – is seized upon in this area that Amyvid has found favour with regulators.
And despite its limitations the test is a step forward in diagnosing the disease, which is often advanced before patients are asked to take a standard mental reasoning test.
Lilly is well aware that research here is littered with failures: its Alzheimer’s candidate solanezumab failed last year in two key Phase III trials.
But the manufacturer remains heavily involved, providing two compounds free of charge to US investigators conducting a worldwide trial of Alzheimer’s.
Adam Hill
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