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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins