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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

* On March 20, 2014,  Piramal Imaging announced that the FDA has approved Neuraceq™. Neuraceq™ is 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) and other causes of cognitive decline. The FDA approval of Neuraceq™ is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq™ accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life. Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq™. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.

* On 19 December 2013, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Neuraceq® with the following therapeutic indication: “This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical 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  and other causes of cognitive impairment. Neuraceq® should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.