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Amyvid (Florbetapir (18F)) Solution For Injection Approved In EU For Patients With Cognitive Impairment

(NYSE: LLY) and , , a wholly owned subsidiary of Lilly, today announced has approved (Florbetapir (18F)) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with who are being evaluated for Alzheimer’s disease (AD) and other causes of . Amyvid should be used in conjunction with a clinical evaluation.1 Amyvid binds to amyloid plaques, a neuropathological feature of AD,2,3,4 and is detected using PET scan images of the brain.1

“Amyvid is the first and only diagnostic tool approved for use in the European Union that can show the presence or absence of beta-amyloid neuritic plaque density in the brain,” said Diane Bakaysa, Amyvid global brand development leader at Lilly. “Amyvid, along with clinical evaluation, may be an important tool to help physicians who are managing patients with cognitive impairment. This is important because it is estimated that one in five patients clinically diagnosed with Alzheimer’s disease during life were ultimately misdiagnosed and do not exhibit Alzheimer’s disease pathology upon autopsy.” 5,6

Confirming the presence or absence of beta-amyloid plaques in patients with cognitive impairment is important because there are many possible underlying causes, including AD, neurological disorders, blood vessel-related disorders causing vascular dementia, movement disorders, brain tumors, normal pressure hydrocephalus and infections such as HIV.7

A negative Amyvid scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. A positive scan indicates moderate to frequent plaques, but does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia).

Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F).1

Initially, Amyvid will be available in select areas within the European Union (EU) beginning in the second quarter of 2013. The time between when Amyvid is approved and when it becomes available allows imaging centers to prepare to place and receive orders for Amyvid on behalf of patients, as well as for Lilly to pursue reimbursement options in the European marketplace. Alzheimer’s disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition. Alzheimer’s disease is a fatal illness, accounting for 60 to 80 percent of dementia cases.4 Alzheimer’s Disease International (ADI) estimates that there are currently 35.6 million people with dementia worldwide, with 7.7 million new cases each year (which implies one new case every four seconds). The number of people affected is estimated to be over 115 million by 2050.8

The approval of Amyvid was based on data submitted by Lilly, including several trials supporting the safety, technical and diagnostic performance of Amyvid. In the pivotal study involving end of life patients, the diagnostic performance of Amyvid to detect the cortical neuritic plaque density (no or sparse versus moderate or frequent) was evaluated in 59 subjects who underwent an Amyvid PET scan and then had neuropathological evaluation of beta-amyloid deposition in the brain after death. In the 59 subjects, a blinded PET reading by five nuclear medicine physicians resulted in a majority read sensitivity of 92 percent (95 percent CI: 78 – 98 percent) and specificity of 100 percent (95 percent CI: 80 – 100 percent). Sensitivity is the ability to appropriately detect moderate or frequent plaques and specificity is the ability to appropriately detect sparse or no plaques. In a study of 47 young (<40 years), healthy volunteers, presumed to be free of beta-amyloid, all Amyvid PET scans were negative.1

Adverse reactions have been collected in clinical studies involving 555 subjects and 665 administrations of Amyvid solution for injection. No serious adverse reactions related to Amyvid administration have been reported. The only adverse reaction considered to be common (defined as ≥1/100 to <1/10) is headache. Uncommon (defined as ≥1/1,000 to <1/100) adverse reactions reported included dysgeusia, flushing, nausea, pruritis, urticarial and infusion site rash.1 Amyvid was approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S. in April 2012.9


1 Amyvid [package insert]. European Union. Eli Lilly & Co.; 2013.

2 Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging–Alzheimer’s Association guidelines for the neuropathologic assessment of Alzheimer’s Disease. Alzheimers Dement. 2012;8:1-13.

3 Mirra SS, Heyman A, McKeel D, et al; and participating CERAD neuropathologists. The Consortium to Establish a Registry for Alzheimer’s Disease (CERAD): part II: standardization of the neuropathologic assessment of Alzheimer’s disease. Neurology. 1991;41(4):479–486.

4 Thies W, Bleiler L; Alzheimer’s Association. Alzheimer’s Association report: 2012 Alzheimer’s disease facts and figures. Alzheimers Dement. 2012;8:131-168.

5 Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of Alzheimer’s disease in a community- based case series. J Am Geriatr Soc. 1999;47(5):564–569.

6 Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001;57(2):226–234.

7 Dementia: Hope Through Research. National Institute of Neurological Disorders and Stroke website. http://www.ninds.nih.gov/disorders/dementias/detail_dementia.htm. Accessed November 13, 2012.

8 Alzheimer’s Disease International, World Health Organization. Dementia: a public health priority. http://whqlibdoc.who.int/publications/2012/9789241564458_eng.pdf. Published 2012. Accessed November 15, 2012. 9 Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.

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