GE Healthcare imaging agent accepted for regulatory review

GE Healthcare has announced that its investigational positron emission tomography amyloid imaging agent [18F]flutemetamol is set to undergo review by key regulatory bodies in the US and Europe.

The US Food and Drug Administration and European Medicines Agency are to assess the product for 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 disorders.

GE Healthcare's applications to the regulators have been accepted on the basis of clinical trial results showing the agent's consistent performance when compared with histopathology data.

Moreover, the company recently struck a deal with Merck Sharp and Dohme for the use of [18F]flutemetamol to help select patients for clinical trials of the new Alzheimer's therapy MK-8931.

Dr Jonathan Allis, general manager for PET at GE Healthcare Medical Diagnostics, said: "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."