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FDA approves new beta-amyloid PET agent

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March 20, 2014 - There are an estimated 7.7 million new cases of dementia each year worldwide, with Alzheimer's disease (AD) accounts for 60% to 80% of diagnoses. Confirming the cause of cognitive impairment can be difficult, and studies suggest that AD is incorrectly diagnosed in 10% to 30% of cases, meaning that people who receive these diagnoses are likely not offered treatments that may be available for other forms of cognitive decline.

Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™, a florbetaben F18 injection indicated for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.

A negative Neuraceq scan indicates sparse to no amyloid 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 Neuraceq 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.  A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. 

Neuraceq is an adjunct to other diagnostic evaluations. Safety and effectiveness of Neuraceq have not been established for predicting development of dementia or other neurologic conditions or for monitoring responses to therapies.

 

 


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