CHMP recommends Vizamyl for Imaging Amyloid-GE Healthcare
The European Medicines Agency�s Committee for Medicinal Products for Human Use (CHMP) recommends the granting of a marketing authorisation for Vizamyl (Flutemetamol F18 injection), from GE Healthcare, 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.
The decision 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 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.
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