Cardinal Health today announced that it will manufacture and distribute Amyvid, Eli Lilly and Company's new diagnostic imaging agent that aids in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. The commercial launch of Amyvid is scheduled for June 1, 2012.
Amyvid works by binding to amyloid plaques, one of the necessary pathological features of Alzheimer's Disease, and is detected using PET scan images of the brain. A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease. A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.
It is important to note that Amyvid is an adjunct to other diagnostic evaluations, and a positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or when used to monitor responses to therapies.
Radioactive agents like Amyvid are often likened to "shrinking ice cubes," because once they are manufactured, their radioactivity quickly decays. Amyvid loses over half of its radioactivity every two hours, so the sites that manufacture it need to be located in close proximity to hospitals and health centers that will use it.
Cardinal Health will manufacture and distribute Amyvid at seven sites throughout the U.S. beginning in June 2012, with a potential expansion to 12 locations by the end of the calendar year.