FDA, EMA to review florbetaben

The FDA and the European Medicines Agency (EMA) have accepted Piramal Imaging’s applications for review of the investigational PET amyloid imaging agent [18F] florbetaben.

A New Drug Application was submitted to the FDA and a Marketing Authorization Application to the EMA for florbetaben use in the visual detection of beta-amyloid in the brains of adults with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Florbetaben binds to beta-amyloid plaques in the human brain, a hallmark characteristic in Alzheimer's disease. Florbetaben is being studied to determine its potential ability to detect beta-amyloid plaques in living subjects with cognitive impairment.

The submission of florbetaben is based on the results of a clinical program including a multicenter Phase III trial, which entailed a direct comparison between in-vivo PET imaging of the brain using florbetaben and the post-mortem analysis of brain tissue. The study was performed to confirm that florbetaben binds to beta-amyloid in the brain at the regional level and is diagnostically useful on the subject to exclude Alzheimer's disease. The presence of beta-amyloid in histopathological sections taken from the brains of deceased subjects was matched to florbetaben uptake in the identical regions of interest, according to Mumbai, India-based Piramal.

The visual assessment procedure proposed for routine clinical practice demonstrated 100 percent sensitivity, 92 percent specificity, and excellent inter-reader agreement, the company summed.