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 [18F]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 [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.
"In clinical trials, [18F]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 [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. 1,2 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,” said Jonathan Allis, PhD, General Manager, PET, GE
Healthcare Medical Diagnostics. "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.”
GE’S COMMITMENT TO IMAGING RESEARCH
[18F]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.
ABOUT GE HEALTHCARE
GE Healthcare provides transformational medical technologies and
services that are shaping a new age of patient care. Our broad expertise
in medical imaging and information technologies, medical diagnostics,
patient monitoring systems, drug discovery, biopharmaceutical
manufacturing technologies, performance improvement, and performance
solutions services helps our customers deliver better care to more
people around the world at a lower cost. In addition, we partner with
healthcare leaders, striving to leverage the global policy change
necessary to implement a successful shift to sustainable healthcare
systems.
Our "healthymagination" vision for the future invites the world to join
us on our journey as we continuously develop innovations focused on
reducing costs, increasing access, and improving quality around the
world. Headquartered in the United Kingdom, GE Healthcare is a unit of
General Electric Company (NYSE:GE). Worldwide, GE Healthcare employees
are committed to serving healthcare professionals and their patients in
more than 100 countries. For more information about GE Healthcare, visit
our web site at www.gehealthcare.com.
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1 Ikonomovic M, Buckley C, Smith A et al. [18F]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 [18F]Flutemetamol
PET and amyloid-ß pathology. Poster presented at: 64th Annual Meeting of
the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.
