Piramal Imaging announced that the FDA has accepted for review its New Drug Application (NDA) for the investigational positron emission tomography (PET) amyloid imaging agent [18F] florbetaben for 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 is an 18F-labeled tracer for use in PET which specifically binds to beta-amyloid deposits in the brain, a key pathological hallmark in Alzheimer’s disease.
The submission of [18F] florbetaben is based on results of a broad clinical program including a pivotal multi-center Phase 3 trial. This was the first study directly comparing in-vivo PET imaging of the brain using [18F] florbetaben to 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 brains of deceased patients 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 1, 2, and 3 studies to validate that the visual assessment method, taught by an electronic tool, is reliable (kappa = 0.87).
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