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Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by the FDA and EMA for the Visual Detection of beta-amyloid in Alzheimer's Disease
Date:3/21/2013

l. This was the first study of a direct comparison between in-vivo PET imaging of the brain using [18F] florbetaben and the post-mortem analysis of brain tissue. The study was performed to confirm that [18F] florbetaben binds to beta-amyloid in the brain at the regional level and is diagnostically useful on the subject to exclude Alzheimer's disease. The presence of beta-amyloid in histopathological sections taken from the brains of deceased subjects was directly matched to [18F] florbetaben uptake in the identical regions of interest. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity, 92% specificity, and excellent inter-reader agreement (kappa = 0.88). In addition, a subsequent study looked across 461 images from Phase I, II, and III studies to validate that the visual assessment method, taught by an electronic tool, is reliable (kappa = 0.87).

"The acceptance for review of [18F] florbetaben marks an important milestone in our clinical research on Alzheimer's disease. The addition of [18F] florbetaben PET imaging to the current clinical evaluation of people suffering from cognitive decline may help to increase the diagnostic confidence of physicians addressing a significant medical need by providing earlier and more robust information to people and their caregivers. We also see a potential for our product to contribute in the future to the early detection of Alzheimer's disease and facilitate specific treatment decisions," said Dr. Ludger Dinkelborg , Director of the Board, Piramal Imaging SA. Renaud Dehareng, Chief Executive Officer of IBA Molecular, also welcomed the acceptance for review of [18F] florbetaben. In 2012 IBA Molecular and Piramal Imaging signed an agreement to the effect that IBA Molecular would manufacture and distribute [18F] florbetaben upon regulatory approval in both th
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SOURCE Piramal Enterprises Ltd.
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