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Lilly Supports The Medical Community's Testimony On The Clinical Utility Of Beta-Amyloid Imaging Agents, Such As Amyvid™ (Florbetapir F 18 Injection), During CMS Public Hearing

"These diagnostic imaging agents allow physicians to determine – for the first time – whether living patients have beta-amyloid plaques in their brain," said Mark Mintun, M.D., chief medical officer, Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly. "This information may impact how physicians ultimately treat their patients by helping inform diagnostic decisions. However, patient outcomes are largely due to the physician's ability to make an accurate diagnosis and recommend an appropriate treatment plan."

About Alzheimer's Disease  By 2030, the total number of Americans aged 65 and over with Alzheimer's Disease is expected to reach 7.7 million. 3 In response to this mounting national health threat, the National Alzheimer's Project Act has brought about renewed urgency and focus on developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease. 4

Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms, including deficiencies in memory, visuospatial ability, executive function, behavior and language. 5,6 Furthermore, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life and do not exhibit Alzheimer's Disease pathology upon autopsy. 7,8

About Amyvid Amyvid is a radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 (F 18) isotope produces a positron signal, which is detected by a PET scanner. Physicians who read Amyvid PET scans should complete a comprehensive training program available through live events or online at AmyvidTraining.com.

Indications and Usage Amyvid is 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 Alzheimer's Disease (AD) and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no 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 Amyvid 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. Amyvid is an adjunct to other diagnostic evaluations.

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