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GE Healthcare Announces European Union Approval of VIZAMYL™ (Flutemetamol (18F) Solution for Injection) for PET Imaging of Beta Amyloid Plaque in Suspected Alzheimer’s Disease
|By Business Wire
|September 1, 2014 03:00 AM EDT
GE Healthcare announced today that VIZAMYL™ (flutemetamol (18F)
solution for injection) has received marketing authorisation from the
European Commission as 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 the only PET imaging tracer for
detection of amyloid approved in Europe for visual interpretation of
colour images and will be commercially available in selected European
countries from early 2015. VIZAMYL™ is for diagnostic use only and
should be used in conjunction with a clinical evaluation.
VIZAMYL™ PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right). Images from VIZAMYL, European Summary of Product Characteristics. Reference: http://www.ema.europa.eu/ema Date: August 2014
“Dementia is one of the biggest health and social challenges in the
world and receiving marketing authorisation for VIZAMYL in the European
Union (EU) demonstrates our continued commitment to helping to meet this
challenge and support the diagnosis of Alzheimer’s disease” said Kieran
Murphy, President and CEO, Life Sciences, GE Healthcare. “This approval
will provide physicians in the EU with an important tool that may
help them better assess specific patients who are being evaluated for
Alzheimer’s disease and will also support further research into greatly
needed disease modifying agents.”
Alzheimer's disease, the leading cause of dementia, can be challenging
to diagnose, as many of the symptoms are similar to other causes of
cognitive impairment1. When used in conjunction with a
clinical evaluation, using VIZAMYL to detect the accumulation of beta
amyloid in the brain may help to confirm an Alzheimer’s disease
diagnosis and could potentially have an impact on earlier patient
management, including the treatment of symptoms.
“VIZAMYL can help with diagnosis in certain individuals, providing
patients and caregivers, along with their healthcare professionals, the
opportunity to determine appropriate treatment options and plan for the
future,” said Professor Philip Scheltens, Professor of Cognitive
Neurology and Director of the Alzheimer Center at the VU University
Medical Center, Amsterdam. “Because Alzheimer’s disease and dementia
continue to be a major burden on healthcare and society, it is equally
important that VIZAMYL will help support and guide further clinical
research that is vital in order to develop disease modifying agents.”
Even though disease modifying agents are not yet available, new
research released from the GE Healthcare-sponsored Value of Knowing
Survey 20142 revealed an overwhelming demand to know about a
neurological diagnosis in oneself or their loved ones, even in absence
of a cure. The survey found that 74% of respondents would want to know
their neurological disease diagnosis, even if there is no cure, and 81%
would want to know the diagnosis if someone close to them had an
incurable neurological disorder. The ‘Value of Knowing’ is a global
survey of 10,000 adults across 10 countries exploring perspectives on
incurable neurological disorders including Alzheimer’s (AD) and
Parkinson’s (PD). The research was conducted by Millward Brown during
June 2014 across 10 countries – Australia, Brazil, China, India,
Indonesia, Japan, Russia, South Korea, UK and USA – with 1,000
nationally –representative adult respondents in each market.
The marketing authorisation for VIZAMYL was based on review of
data from a series of Phase III clinical trials, including brain autopsy
studies which showed high sensitivity and specificity for visual
interpretation of flutemetamol (18F) PET images, using beta
amyloid pathology as the standard of truth.3,4 Additionally,
to instruct physicians in accurate interpretation of VIZAMYL images, GE
Healthcare has developed an electronic reader training program (ETP),
which, following approval, will be offered free of charge as online and
in-person training in the European Union. Images should be interpreted
only by readers who have completed the GE Healthcare electronic reader
GE’S COMMITMENT TO IMAGING RESEARCH
VIZAMYL, flutemetamol (18F) 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
these diseases. 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 reporting tools.
Additionally, GE Healthcare is collaborating with other companies in the
pharmaceutical industry to assist in their development of the next
generation of therapies. To that end, work is ongoing with potential
partners in the industry to understand their strategic needs, and
helping to provide imaging support for clinical trials of therapeutic
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
1Alzheimer’s Association. What is Dementia Patient
Information. Available at http://www.alz.org/what-is-dementia.asp.
Last accessed August 2014.
2 Value of Knowing 2014. GE Healthcare. Data on file.
3 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.
4 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-β pathology. Poster presented at: 64th Annual Meeting of
the American Academy of Neurology, April 21-28, 2012; New Orleans, LA.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20140901005048/en/
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