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FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Date:4/6/2012

pon autopsy,[8] physicians rely on medical history, clinical examination and a variety of diagnostic tools when evaluating patients.[4]

"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,"[9],[10] said Daniel Skovronsky, M.D., Ph.D., president and CEO 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."

Amyvid was evaluated in three clinical studies that examined images from healthy adult patients as well as patients with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program. Based on the results of study one, measurements of postmortem cortical amyloid burden correlated with median Amyvid scores (r=0.78; P<0.0001). In the second study, using the majority interpretation of five readers, Amyvid PET showed 96 percent sensitivity and 100 percent specificity in patients who received an Amyvid PET scan within one year of death. Across all readers and all autopsied patients, Amyvid PET demonstrated median sensitivity of 92 percent (range 69 percent to 95 percent) and specificity of 95 percent (range 90 percent to 100 percent) for readers trained in person (study two), and median sensitivity of 82 percent (range 69 percent to 92 percent) and specificity of 95 percent (range 90 percent to 95 percent) for readers trained using an electronic media-based training (study three). Additionally, inter-reader reproducibility analysis for all images in study three showed an overall Fleiss' kappa statistic of 0.83 (95 percent CI: 0.78 to 0.88). The most common adverse reactions reported in clinical trials were headache (1.8 percent), musculoskeletal pain (0.8 percent), fatigue (
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SOURCE Eli Lilly and Company
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