Eli Lilly & Co Imaging Agent Rejected by US for Brain Plaque Link to Alzheimer’s Disease
In statement the US advisors announced that they have turned down an Eli Lilly & Co imaging agent explaining that the data given is not sufficient to approve the drug for helping doctors to rule out the presence of plaque which is linked to the Alzheimer's disease.
The move by the Food and Drug Administration's outside advisors on Thursday, it is said to be a set back as it has been one of the most promising imaging tests to help researchers and physicians to grapple with the commonest form of dementia.
The Panel Chairman Dr. Britt Anderson, a psychology professor at the University of Waterloo, said, "The information is useful, and I do think it has clinical utility. But for me it's a problem that the readings thus far are significantly inconsistent."
The Company is seeking the FDA approval to market the agent which is known as Amyvid. It is used with position emission tomography or PET, and scans to help doctors rule out the plaque linked with the Alzheimer's disease. However, it does not help in diagnosing the disease.
The Company is ahead in the race for such imaging agents that have an estimated $1 billion to $5 billion potential global market.
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