Amyvid nabs European Union approval
Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for 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 (AD) and other causes of cognitive impairment.
Beginning in the second quarter 2013, Amyvid will be available in select areas within the European Union, according to Indianapolis-based Eli Lilly.
A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition, according to Eli Lilly.
Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.