Eli Lilly and Company announced today that the Amyvid (Florbetapir (18F) solution, a radioactive agent used in PET brain scans that evaluate patients for Alzheimer's disease and other cognitive impairments, has been approved by the European Commission for diagnostic use.

One of the hallmarks of Alzheimer's disease is the accumulation of amyloid plaque, which degrades neurons in the brain and subsequently contributes to symptoms of Alzheimer's disease. Amyloid plaque may also indicate other serious cognitive impairments including neurological disorders, blood vessel-related disorders causing vascular dementia, movement disorders, brain tumors, normal pressure hydrocephalus and infections such as HIV.

Amyvid works by binding to amyloid plaque present in the brain, making the plaque visible in PET scans. A high presence of plaque indicates a stronger likelihood that the patient may have Alzheimer's Disease, though the scan on its own should not be used to independently establish a diagnosis.
Prior to this approval, the only way doctors could measure the presence of amyloid plaque was by autopsying the brain after death. In the future, using this new diagnostic tool may help physicians not only monitor and treat disease progression, but also diagnose disease more accurately. Studies show that up to one in five patients clinically diagnosed with Alzheimer's disease during life are ultimately misdiagnosed and do not exhibit Alzheimer's disease pathology upon autopsy.

Amyvid has already been approved for use in the United States by the FDA, and will be available in select areas within the European Union starting in the second quarter of 2013.

More Industry Headlines