FDA approves Lilly's imaging agent Amyvid

FDA approved Amyvid florbetapir from Eli Lilly and Co. (NYSE:LLY) as a PET imaging agent to estimate beta amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Lilly will launch the imaging agent beginning in June at a limited number of radiopharmacies. The wholesale acquisition cost (WAC) for Amyvid is $1,600 per dose.

Amyvid's label notes that a negative scan indicates sparse to no neuritic plaques and reduces the likelihood that a patient's cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques, which the label says has been shown to be present in AD patients, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. A positive scan does not establish an AD diagnosis, or other cognitive disorder. The product is an adjunct to other diagnostic evaluations. The label also notes that Amyvid scans should only be interpreted by readers who have completed Lilly's online or in-person training program. ...