- Supporting Electronic Reader Training Program launched to train physicians to interpret images taken using PET imaging with Vizamyl™
- Vizamyl to be commercially available in late 2Q 2014
Princeton, NJ -- April 29, 2014 -- 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.[i] 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.[ii],[iii]
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.
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[i] Alzheimer's Association 2014 Alzheimer's Facts and Figures, Alzheimer's & Dementia, Volume 10, Issue 2.
[ii] 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.
[iii] 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.