Date: 2014-03-20
Type of information: Granting of a Market Authorisation in the US
Product name: Neuraceq®
Compound: florbetaben 18F
Therapeutic area: Neurodegenerative diseases - Diagnostic
Action mechanism:
Company: Piramal Imaging (Germany - India)
Disease:
Latest news: * 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-03-20
UE authorization: 2014-02-20
Favourable opinion UE: 2013-12-19
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: