PRINCETON, N.J.--(BUSINESS WIRE)--October 25, 2013--
GE Healthcare today announced the U.S. Food and Drug Administration (FDA) approval of Vizamyl(TM) (Flutemetamol F18 injection), a radioactive diagnostic agent indicated for Positron Emission Tomography (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 (AD) or other causes of cognitive decline. Vizamyl is an adjunct to other diagnostic evaluations.(1) Vizamyl is the only PET imaging tracer for detection of amyloid approved by FDA for visual interpretation of color images rather than black and white assessment, and will be commercially available in 2014.(1)
Increased levels of beta amyloid plaque is a defining pathological feature of AD, the most common form of dementia and the sixth leading cause of death in the United States.(2) Normally, beta amyloid is broken down and eliminated, but in individuals with AD, amyloid plaque builds up and can negatively impact neuronal function.(3) Currently, possible or probable AD is diagnosed following a thorough clinical examination.(2)
"Vizamyl represents a new and important option to augment the current methods we have available to evaluate patients with symptoms of Alzheimer's disease," said William E. Klunk, M.D., Ph.D., Co-director, Alzheimer Disease Research Center, and Distinguished Professor of Psychiatry and Neurology at the University of Pittsburgh. "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."
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 [(18) F]flutemetamol PET images compared to 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. (4,5)
Additionally, GE Healthcare developed and validated an electronic reader training program (ETP) to instruct physicians in accurate interpretation of Vizamyl images. In the validating clinical trial, the ETP was effective (high sensitivity, specificity, and reader agreement) in training readers who were naïve to amyloid imaging. 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.
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.(1) One subject had a serious hypersensitivity reaction (flushing, dyspnea, and chest pressure) within minutes following Vizamyl administration and recovered with treatment.
"The approval of Vizamyl for PET imaging underscores GE Healthcare's commitment to provide medical imaging that to help physicians deliver better care to more people," said Kieran Murphy, President and CEO, GE Healthcare Life Sciences. "We hope that Vizamyl will help advance treatment options by helping to enroll the right people into the right clinical trials, which may lead to disease-modifying medications."
Important Risk and Safety Information about Vizamyl (Flutemetamol F18 Injection)
INDICATIONS AND USAGE: Vizamyl is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate
Prior to Vizamyl (flutemetamol F18) administration, please read the Full Prescribing Information
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(1) Vizamyl Prescribing Information. 2013.
(2) Alzheimer's Association. Alzheimer's disease facts and figures. Alzheimer's & Dementia. 2012;8:131--168.
(3) Rodrigue K, Kennedy K, Park D. Beta-amyloid deposition and the aging brain. Neuropsychol Rev. 2009;19:436--450.
(4) Ikonomovic M, Buckley C, Smith A et al. [(18) F]Flutemetamol injection PET images reflect brain amyloid levels. Data presented at Alzheimer's Association(R) International Conference 2012 (AAIC 2012), Vancouver, BC, Canada.
(5) Wolk D, Gamez J, Sadowsky C et. al. Brain autopsy and in vivo cortical brain biopsy trials show a strong concordance between [(18) F]Flutemetamol PET and amyloid-
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SOURCE: GE Healthcare Copyright Business Wire 2013