US FDA, EMEA accept GE Healthcare’s review applications for [18F] Flutemetamol

GE Healthcare announced that regulatory bodies in the US and Europe have accepted its applications for review of the investigational positron emission tomography (PET) amyloid imaging agent [18F]flutemetamol, a PET imaging agent.

A New Drug Application (NDA) was submitted to the US Food and Drug Administration (US FDA) for [18F]flutemetamol 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. Additionally, a Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for AD.

William E Klunk, Co-director, Alzheimer Disease Research Center, Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh, said, “In clinical trials, [18F]flutemetamol imaging demonstrated consistent performance in the visual detection of beta amyloid in the brain when compared with histopathology data. PET scanning with [18F] flutemetamol has the potential to augment the current methods used in the evaluation of patients with symptoms of Alzheimer’s disease.”

The accumulation of beta amyloid in the brain is a key pathological characteristic of AD, which is primarily diagnosed following thorough clinical examinations (i.e., medical history, physical, neurological, psychiatric and neuropsychological exams, laboratory tests and magnetic resonance imaging (MRI) or computed tomography (CT) scans). [18F]Flutemetamol is being studied to determine its potential ability to detect beta amyloid deposition in living humans.

The NDA and MAA submissions are based on data from a series of clinical trials, including phase III 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. Data from these studies were presented at the Alzheimer’s Association International Conference 2012 (AAIC 2012) in Vancouver and the American Academy of Neurology’s (AAN) 64th Annual Meeting in New Orleans. The filing also includes data from a recently completed [18F]flutemetamol PET image reader training validation study, results of which will be presented at a scientific forum in coming months.

“Acceptance of these applications further strengthens GE Healthcare’s commitment towards the early and accurate detection of Alzheimer’s disease pathology and to improving the quality of life for patients and their caregivers. PET imaging with [18F]flutemetamol has the potential to be part of a larger diagnostic workup that may help doctors rule out Alzheimer’s disease by reliably showing the absence of beta amyloid deposits in patients with unexplained loss of cognitive function,” said Jonathan Allis, General Manager, PET, GE Healthcare Medical Diagnostics.

EP News Bureau – Mumbai