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 appropriate 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. 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.
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