GE Healthcare today announced the first seven markets where Vizamyl™
(Flutemetamol F18 injection), a radioactive diagnostic agent approved by
the FDA will be available. Late in the second quarter of 2014, Vizamyl
will be available to imaging centers near East Rutherford, NJ, Woburn,
MA, Beltsville, MD, East Lansing, MI, Dallas, TX, Phoenix, AZ and
Colton, CA. Vizamyl is indicated for PET imaging of the brain to
estimate beta amyloid neuritic plaque density in adult patients with
cognitive impairment who are being evaluated for Alzheimer’s disease or
other causes of cognitive decline. Vizamyl is an adjunct to other
diagnostic evaluations. The safety and effectiveness of Vizamyl have not
been established for predicting the development of dementia or other
neurologic conditions or for monitoring responses to therapies. Vizamyl
is the only PET imaging tracer for detection of amyloid approved by FDA
for visual interpretation of color images.
In conjunction with the availability of Vizamyl, GE Healthcare has
developed and launched an electronic reader training program. Vizamyl
images should be interpreted only by readers who have completed the GE
Healthcare electronic reader training program. This program trains
physicians on instructs physicians in the appropriate method to
interpret Vizamyl images and can be accessed by healthcare professionals
online at www.ReadVizamyl.com.
In a clinical trial that validated the use of the training program, it
was shown to be highly effective in training readers without amyloid
imaging experience, as measured by sensitivity, specificity, and reader
agreement.
“The commercial availability of Vizamyl and rollout of the electronic
training program represent our commitment to helping physicians deliver
more accurate and timely assessments of patients with cognitive
disorders,” said Ben Newton, Director of PET Neurology, GE Healthcare
Life Sciences. “The ability to detect or exclude the presence of beta
amyloid plaques in the brain may help physicians make more accurate
assessments of patients with suspected cognitive disorders, including
AD.”
An estimated 5.2 million Americans have Alzheimer’s disease and the
disease affects one in nine people aged 65 and older.1 The
healthcare costs for 2014 are estimated to be $214 billion for those
with Alzheimer’s disease and other dementia.1
Clinical Trial Results Supporting FDA Approval
The FDA approval of Vizamyl is based on review of pivotal and supportive
data from a series of clinical trials, including Phase III brain autopsy
and biopsy studies which showed high sensitivity and specificity for
visual interpretation of [18F]flutemetamol PET images
compared to beta amyloid brain pathology.2,3
In the clinical trials, Vizamyl was generally well tolerated. The most
common adverse reactions reported in clinical trials were flushing,
increased blood pressure, headache, nausea and dizziness, and occurred
at rates 2% or less. One subject had a serious hypersensitivity reaction
(flushing, dyspnea, and chest pressure) within minutes following Vizamyl
administration and recovered with treatment.
Important Risk and Safety Information About Vizamyl™ (Flutemetamol F
18 Injection)
INDICATIONS AND USAGE: Vizamyl is indicated for positron-emission
tomography (PET) imaging of the brain to estimate β-amyloid neuritic
plaque density in adult patients with cognitive impairment who are being
evaluated for Alzheimer’s disease (AD) and other causes of cognitive
decline. A negative scan indicates sparse to no neuritic plaques,
inconsistent with a diagnosis of AD at the time of image acquisition. A
negative scan result reduces the likelihood that a patient’s cognitive
impairment is due to AD. A positive scan indicates moderate to frequent
amyloid neuritic plaques. This amount of amyloid neuritic plaque has
been shown to be present in patients with AD but may also be present in
patients with other neurologic conditions as well as in older people
with normal cognition. Vizamyl is an adjunct to other diagnostic
evaluations. Limitations: A positive scan does not establish a
diagnosis of AD or other cognitive disorder. The safety and
effectiveness of Vizamyl have not been established for predicting the
development of dementia or other neurologic conditions or for monitoring
responses to therapies. CONTRAINDICATIONS: Known hypersensitivity
to Vizamyl or any excipient, including polysorbate 80. WARNINGS AND
PRECAUTIONS — Hypersensitivity Reactions: Reactions such as flushing
and dyspnea have been observed within minutes following administration
and may occur in patients with no history of exposure to Vizamyl. Have
resuscitation equipment and trained personnel available. Image
Misinterpretation: Errors may occur while interpreting Vizamyl PET
images. Image interpretation is performed independently of the patient’s
clinical information. The use of clinical information in the
interpretation of Vizamyl images has not been evaluated and may lead to
errors. Extensive brain atrophy may limit the ability to distinguish
grey and white matter on a Vizamyl scan. Motion artifacts may distort
the image. Images should be interpreted only by readers who have
completed a reader training program available from GE Healthcare. Radiation
Risk: Like all radiopharmaceuticals, Vizamyl contributes to a
patient’s long-term, cumulative radiation exposure and cancer risk.
Ensure safe handling to protect patients and healthcare workers from
unintentional radiation exposure. ADVERSE REACTIONS: The most
commonly reported adverse reactions in NDA clinical trials were flushing
(2%) and increased blood pressure, headache, nausea, and dizziness (at
1% each). DRUG INTERACTIONS: Drug-drug interaction studies have
not been performed in patients to establish the extent, if any, to which
concomitant medications may alter Vizamyl image results. SPECIFIC
POPULATIONS — Pregnancy: It is not known whether Vizamyl can cause
fetal harm when administered to a pregnant woman or if it can affect
reproductive capacity. Radiopharmaceuticals, including Vizamyl, have the
potential to cause fetal harm, the likelihood of which depends on the
stage of fetal development and the magnitude of the radiopharmaceutical
dose. Vizamyl should be given to a pregnant woman only if clearly
needed. Nursing Mothers: It is not known whether flutemetamol is
excreted in human milk. Because many drugs are excreted in human milk
and there is a potential for radiation exposure to nursing infants,
avoid use of Vizamyl in a breastfeeding mother or have the mother
temporarily interrupt breastfeeding for 24 hours after exposure. Pediatric
Use: Vizamyl is not indicated for use in pediatric patients. Geriatric
Use: No overall differences in safety were observed between older
and younger subjects. OVERDOSAGE: The clinical consequence of
overdosing with Vizamyl has not been reported. It is unknown whether or
not flutemetamol is dialyzable. In case of overdose of radioactivity,
hydration and frequent urination should be encouraged.
Prior to Vizamyl administration, please read the Full
Prescribing Information.
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 provide quantification, optimized visualization and
reporting tools.
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 Alzheimer’s Association 2014 Alzheimer’s Facts and Figures, Alzheimer’s
& Dementia, Volume 10, Issue 2.
2 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.
3 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.
Copyright Business Wire 2014