CHMP recommends NeuraCeq for PET imaging of beta amyloid plaque-Piramal Imaging
Piramal Imaging announced the European Union�s Committee for Medicinal Products for Human Use (CHMP) recommended approval of NeuraCeq(florbetaben 18F) (formerly BAY 94-9172). The CHMP's recommendation will now be referred to the European Commission, for approval in the European Union (EU).
NeuraCeq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of neuritic beta-amyloid 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.
The CHMP�s positive opinion was based on data from the pivotal phase III autopsy study, which showed that PET imaging with NeuraCeq detects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 percent sensitivity and 86 percent specificity.
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