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FDA Slams Eli Lilly and Company (LLY) Over Amyvid Site


9/7/2012 6:48:20 AM

Earlier this year, the FDA approved an imaging agent from Eli Lilly for detecting beta-amyloid plaques in patients with cognitive impairment and who are being evaluated for Alzheimer’s disease. Known as Amyvid, this is the first diagnostic agent approved for people who undergo a positron emission tomography, or PET, scan. But the approval was not a slam dunk – the agency initially declined to approve Amyvid over concerns that scans can be accurately read. Now, the FDA has tagged Lilly (LLY) for offering physicians what the agency calls a misleading way to interpret scan results on the Amyvid web site and in recent displays at a medical conference. To wit, Lilly offered a multi-colored image of the brain, when the Amyvid labeling information says PET scans should be displayed and reviewed using a black-and-white scale “with the maximum intensity of the scale set to the maximum intensity of all the brain pixels.”

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