Piramal Imaging announced that NeuraCeq (florbetaben 18F) has received marketing authorisation from the European Commission. According to a company press release, 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.
With this authorisation, NeuraCeq will soon be available to provide valuable information that may give physicians more confidence in their clinical assessment and help them provide more personalised patient management as a negative scan may rule out Alzheimer’s disease as a cause of a patient’s cognitive decline, the press release explains.
“With the prevalence of dementia predicted to grow dramatically in the coming decades, the global communities are mobilising to understand the pathology and progression of Alzheimer’s disease and other forms of cognitive impairment,” says Ludger Dinkelborg, director of the Board, Piramal Imaging. “The approval of NeuraCeq in Europe will give healthcare providers a new tool to aid in the diagnostic assessment of Alzheimer’s disease and other causes of cognitive impairment. Our goal from here is to get NeuraCeq into the hands of physicians later this year so they can help ensure timely and accurate assessments for patients.”
The press release reports that data from the pivotal phase III autopsy study 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% sensitivity and 86% specificity. In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98% and specificity was 89%.
NeuraCeq will be available in select European countries in the second and third quarters of 2014.
Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of NeuraCeq upon EU approval.