The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from GE Healthcare for review of its investigational F-18 flutemetamol PET amyloid imaging agent.
A new drug application (NDA) was submitted to the FDA for the use of F-18 flutemetamol in the visual detection of beta amyloid in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other cognitive disorders, according to GE. The company also filed a marketing authorization application (MAA) with the EMA for the agent's use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for Alzheimer's.
GE said the NDA and MAA submissions are based on data from a series of clinical trials and data from a recently completed F-18 flutemetamol PET image reader training validation study. Results from the training validation study will be presented at a scientific forum in the coming months, according to the vendor.
