Regulatory bodies in the U.S. and Europe have accepted GE Healthcare’s applications for review of the investigational PET amyloid imaging agent [F-18]flutemetamol.
A new drug application (NDA) was submitted to the FDA for [F-18]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 [F-18]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for AD.
“In clinical trials, [F-18]flutemetamol imaging demonstrated consistent performance in the visual detection of beta amyloid in the brain when compared with histopathology data,” William E. Klunk, MD, PhD, co-director, Alzheimer Disease Research Center at the University of Pittsburgh, said in a release. “PET scanning with [F-18]flutemetamol has the potential to augment the current methods used in the evaluation of patients with symptoms of Alzheimer’s disease.”
[F-18]Flutemetamol is being studied to determine its potential capability 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 [F-18]flutemetamol PET images and beta-amyloid brain pathology. The filing includes data from a recently completed [F-18]flutemetamol PET image reader training validation study, the results of which will be presented at a scientific forum in coming months, according to GE.