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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

BOSTON and MUMBAI, India, March 21, 2013 /PRNewswire/ --

Piramal Imaging SA, a division of Piramal Enterprises, today announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted its applications for review of the investigational PET amyloid imaging agent [18F] florbetaben. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the EMA for [18F] florbetaben use in the visual detection of beta-amyloid in the brains of adults with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. [18F] florbetaben binds to beta-amyloid plaques in the human brain, a hallmark characteristic in Alzheimer's disease.

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Today, Alzheimer's disease is usually diagnosed after a person with a cognitive impairment undergoes an extensive clinical examination which typically includes family and medical history, physical and neurological examinations, laboratory tests, and imaging procedures such as computed tomography (CT) and magnetic resonance imaging (MRI) scans. Still, a definitive diagnosis of Alzheimer's disease can only be made after death where an autopsy can reveal the presence of beta-amyloid plaques and neurofibrillary tangles in the brain. However, post-mortem studies looking for accumulations of beta-amyloid in the brain have shown that 10 to 30 percent of diagnoses based on clinical examinations are incorrect. [18F] florbetaben is being studied to determine its potential ability to detect beta-amyloid plaques in living subjects with cognitive impairment.

The submission of [18F] florbetaben is based on the results of a broad clinical program including a pivotal multi-center Phase III tria
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SOURCE Piramal Enterprises Ltd.
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