|[June 30, 2014]
CHMP Recommends EU Approval of VIZAMYL™ (Flutemetamol F18 Injection) for PET Imaging of Beta Amyloid Plaque
CHALFONT ST. GILES, England --(Business Wire)--
GE Healthcare today announced the receipt of a positive opinion from the
European Medicines Agency's Committee for Medicinal Products for Human
Use (CHMP). This opinion recommends the granting of a marketing
authorisation for VIZAMYL™ (Flutemetamol F18 injection), a
radiopharmaceutical medicinal product indicated for Positron Emission
Tomography (PET) imaging of beta amyloid neuritic plaque density in the
brains of adult patients with cognitive impairment who are being
evaluated for Alzheimer's disease (AD) and other causes of cognitive
impairment. VIZAMYL™ is for diagnostic use only and should be used in
conjunction with a clinical evaluation.
"The CHMP positive recommendation further strengthens GE Healthcare's
longstanding commitment to the early and accurate detection of AD
pathology and to improving quality of life for patients and their
caregivers," said Kieran Murphy, President and CEO, Life Sciences, GE
Healthcare. "When approved in the European Union, VIZAMYL will be
an important tool to support assessments of patients with cognitive
disorders, including AD."
PET imaging with VIZAMYL detects the accumulation of beta amyloid in the
brain, one of the pathological in-vivo markers of AD, and allows for
visual interpretation of colour images. While VIZAMYL does not establish
a diagnosis for AD or other cognitive disorders, it is a useful tool in
conjunction with a clinical evaluation, and may have the potential to
lead to earlier diagnosis and intervention in the future.
"AD is a major unmet medical need and the lack of diagnostic tools
increases the potential for diagnostic uncertainty and the risk of
mismanagement," said Professor Philip Scheltens, Professor of Cognitive
Neurology and Director of the Alzheimer Center at the VU University
Medical Center, Amsterdam. "Once approved, VIZAMYL may help physicians
to assess specific patients with suspected Alzheimer's disease. This may
help physicians determine appropriae treatment options, support
patients and caregivers in planning for the future, and support clinical
researchers in identifying patients for clinical trials."
The CHMP positive opinion of VIZAMYL was based on review of
pivotal and supportive data from a series of clinical trials, including
several Phase III brain autopsy and biopsy studies which showed high
sensitivity and specificity for visual interpretation of [18F]flutemetamol
PET images, using beta amyloid pathology as the standard of truth.1,2
In October 2013, the U.S. Food and Drug Administration (FDA) approved
VIZAMYL for PET imaging of the brain to estimate beta amyloid
neuritic plaque density in adult patients with cognitive impairment who
are being evaluated for AD or other causes of cognitive decline.
GE Healthcare has developed and validated an electronic reader training
program (ETP) to instruct U.S.-based physicians in accurate
interpretation of VIZAMYL images. Images should be interpreted
only by readers who have completed the GE Healthcare electronic reader
training program that will be made available free of charge to
healthcare professionals who want to conduct and interpret VIZAMYL imaging.
Upon VIZAMYL approval, online and in-person training will be available
in the European Union.
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 neurology field. GE Healthcare is taking a
comprehensive approach to understanding dementia and 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 provide quantification, optimized visualization and
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 to meet the demand for increased access, enhanced quality and
more affordable healthcare around the world. GE (NYSE: GE) works on
things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and
diagnostics to drug discovery, biopharmaceutical manufacturing
technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients.
For our latest news, please visit http://newsroom.gehealthcare.com
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.
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