On the heels of Amyvid's June 1 release on the U.S. market, Cardinal Health announced it will manufacture and distribute Eli Lilly'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.
Cardinal said it will manufacture and distribute Amyvid at seven sites throughout the U.S. beginning in June, with a potential expansion to 12 locations by the end of the calendar year.
Amyvid works by binding to amyloid plaques, and is detected using PET scan images of the brain, according to the Dublin, Ohio-based company. 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 also may be present in patients with other types of neurologic conditions and in older people with normal cognition.
Cardinal added 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. In addition, 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.