Earlier this week, the US Food and Drug Administration (FDA) approved the radioactive diagnostic agent florbetaben F18 injection (Neuraceq). Florbetaben is used with positron emission tomography imaging of the brain to estimate amyloid beta (Abeta) plaques in adult patients with suspected Alzheimer’s disease or cognitive decline. This is the third such agent to receive approval.
According to the FDA, a negative scan with florbetaben reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s, but a positive florbetaben scan (showing moderate to frequent amyloid neuritic plaques) does not necessarily indicate Alzheimer’s. Although neuropathological examination has shown that moderate to frequent amyloid neuritic plaques are present in patients with Alzheimer’s, these results may also be present in patients with other types of neurologic conditions as well as older people with normal cognition, the FDA warns. Thus, “florbetaben is an adjunct to other diagnostic evaluations.”
This approval is based on safety data from global clinical trials with 872 patients as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of Abeta neuritic plaques, the manufacturer reported. In these 82 subjects, the agent was found to accurately detect moderate to frequent Abeta neuritic plaques in the brain. The agent was also found to estimate accurate density of these plaques in living patients. The product is manufactured by Piramal Imaging.
See our previous coverage of amyloid imaging agents: http://bit.ly/1oGOUeF.