GE Healthcare announced that the FDA has accepted its New Drug Application (NDA) for [18F]flutemetamol for use in the visual detection of beta amyloid in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other cognitive disorders. [18F]flutemetamol is a positron emission tomography (PET) imaging agent.
The NDA submission is based on data from a series of clinical trials, including Phase 3 brain autopsy and biopsy studies which showed high sensitivity and specificity for visual image reads as well as strong concordance between [18F]flutemetamol PET images and beta amyloid brain pathology. The filing also includes data from a recently completed [18F]flutemetamol PET image reader training validation study.
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