GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe
PRINCETON, N.J.--(BUSINESS WIRE)--Jan 8, 2013--GE Healthcare today announced that regulatory bodies in the United States and Europe have accepted its applications for review of the investigational PET amyloid imaging agent [ 18 F]flutemetamol, a positron emission tomography (PET) imaging agent. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for [ 18 F]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 [ 18 F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for AD.
“In clinical trials, [ 18 F]flutemetamol imaging demonstrated consistent performance in the visual detection of beta amyloid in the brain when compared with histopathology data,” said William E. Klunk, MD, PhD, Co-director, Alzheimer Disease Research Center, Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh. “PET scanning with [ 18 F]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). [ 18 F]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 [ 18 F]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. 1,2 The filing also includes data from a recently completed [ 18 F]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,” said Jonathan Allis, PhD, General Manager, PET, GE Healthcare Medical Diagnostics. “PET imaging with [ 18 F]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.” GE’S COMMITMENT TO IMAGING RESEARCH [ 18 F]Flutemetamol is one component of a broad portfolio of investigational diagnostic solutions that GE Healthcare is currently developing in the Alzheimer’s field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. GE Healthcare offers a broad portfolio of imaging resources including cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and is developing image analysis software to help physicians interpret the results.
Additionally, GE Healthcare is collaborating with the pharmaceutical industry to assist in their development of the next generation of therapies. To that end, we are working with potential partners in the industry to understand their strategic needs, and helping to provide imaging support for clinical trials of therapeutic agents.
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For our latest news, please visit http://newsroom.gehealthcare.com 1 Ikonomovic M, Buckley C, Smith A et al. [ 18 F]Flutemetamol injection PET images reflect brain amyloid levels. Data presented at Alzheimer's Association ® International Conference 2012 (AAIC 2012), Vancouver, BC, Canada.
2 Wolk D, Gamez J, Sadowsky C et. al. Brain autopsy and in vivo cortical brain biopsy trials show a strong concordance between [ 18 F]Flutemetamol PET and amyloid-β pathology. Poster presented at: 64th Annual Meeting of the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.CONTACT: GE Healthcare Scott Lerman, 609-514-6346 (office) 609-937-9253 (mobile) firstname.lastname@example.org Aleisia Gibson, 609-514-6046 (office) 201-289-3832 (mobile) email@example.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA NEW JERSEY INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY MEDICAL DEVICES FDA GENERAL HEALTH SOURCE: GE Healthcare Copyright Business Wire 2013 PUB: 01/08/2013 07:00 AM/DISC: 01/08/2013 07:00 AM http://www.businesswire.com/news/home/20130108005396/