Alzheimer's Imaging Agent Recommended for Approval in Europe

Caroline Cassels

October 19, 2012

Following the US Food and Drug Administration's April 9 approval of florbetapir (Amyvid, Eli Lilly, Avid Pharmaceuticals), the diagnostic imaging agent for Alzheimer's disease (AD), a committee of the European Medicines Agency (EMA) has recommended its approval in Europe.

Florbetapir F 18 injection detects beta-amyloid plaques in living patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Tagged with the radioisotope fluorine-18, the agent is used with positron emission tomography (PET) and binds to amyloid plaques in the brain.

It is one of 3 imaging agents in various stages of development that are designed to detect amyloid deposition in the living brain.

According to a release issued by the EMA, AD is the most common form of dementia in the elderly, affecting 5.1 million people in the European Union.

"Accurate diagnosis of AD has been hampered to date by the lack of diagnostic tests. The current gold standard for confirming a clinical diagnosis of AD is post-mortem autopsy," the EMA Committee states.

A negative Amyvid PET scan can rule out the presence of AD and is expected to reduce the frequency of false positive diagnoses. The EMA release notes that a positive scan is consistent with, but does not independently establish, the diagnosis of AD, because beta-amyloid plaque deposition may also be present in asymptomatic patients as well as those with some neurodegenerative dementias, including Parkinson's disease dementia and Lewy body dementia.

"Given the public health burden of AD, there is great interest in the qualification of biomarkers allowing the study of AD earlier in the disease process, and investigating whether the use of potentially disease-modifying agents can alter the long-term course of the illness and prevent the neurodegenerative cascade associated with the disease," the release states.