Eli Lilly and Company LLY
and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly,
announced today that Amyvid (Florbetapir F 18 Injection) has received
marketing authorization from the European Commission as a diagnostic
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. Amyvid should be used in conjunction with a
clinical evaluation.[1]
Alzheimer's Disease is one of many possible causes of cognitive impairment,
which can make diagnosis challenging.[2],[3] Alzheimer's Disease and other
causes of cognitive impairment share many overlapping symptoms, including
deficiencies in memory, visuospatial ability, executive function, behavior,
and language.[2],[3] It is estimated that up to one in five patients
clinically diagnosed with probable Alzheimer's Disease during life do not
exhibit Alzheimer's Disease pathology upon autopsy.[4],[5]
"We believe that Amyvid fills an unmet need in the medical community,
providing physicians with important information about the presence or absence
of beta-amyloid plaques that can help identify the cause of their patients'
cognitive symptoms," said Diane Bakaysa, Amyvid global brand development
leader. "This is important because, if, based on negative Amyvid findings and
clinical assessment, it is determined that Alzheimer's Disease is not the
cause of cognitive impairment, a physician can avoid unnecessary or
potentially harmful treatments associated with a misdiagnosis of Alzheimer's
Disease."[6],[7],[8]
Beginning in Q2 2013, Amyvid will be available in select areas within the
European Union.
Amyvid for intravenous use was approved by the U.S. Food and Drug
Administration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL
multidose vials containing 500–1,900 MBq/mL Florbetapir F 18.[9] Amyvid is
indicated for 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.[9]
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 Amyvid 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.[9]
Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan
does not establish a diagnosis of AD or other cognitive disorder. Safety and
effectiveness of Amyvid have not been established for predicting development
of dementia or other neurologic condition, or monitoring responses to
therapies.[9]
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