FDA Accepts [18F] Florbetaben NDA for Review for PET Imaging

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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