Date: January 15, 2013
For Release: Immediately
Refer to: Celeste Stanley, + 317-478-0263 (mobile), email@example.com
Amyvid (Florbetapir (18F)) Solution for Injection Approved in European Union
for Use in Patients with Cognitive Impairment Being Evaluated for Alzheimer's
Disease and Other Causes of Cognitive Impairment
Amyvid is the first and only PET imaging agent approved to measure beta-amyloid
neuritic plaque density in the living brain
INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals,
Inc., a wholly owned subsidiary of Lilly, today announced the European
Commission has approved Amyvid (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 cognitive impairment who are being evaluated for Alzheimer's disease (AD)
and other causes of cognitive impairment. Amyvid should be used in conjunction
with a clinical evaluation. Amyvid binds to amyloid plaques, a
neuropathological feature of AD,,, and is detected using PET scan images of the
"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." ,
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.
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.
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
Amyvid was approved by the United States (U.S.) Food and Drug Administration
(FDA) for use in the U.S. in April 2012.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most urgent medical
This press release contains certain forward-looking statements about Amyvid™, a
radioactive diagnostic agent indicated for brain imaging of beta-amyloid
plaques in patients with cognitive impairment who are being evaluated for
Alzheimer's Disease and other causes of cognitive decline. This release
reflects Lilly's current beliefs; however, as with any pharmaceutical product,
there are substantial risks and uncertainties in the process of development and
commercialization. There is no guarantee that future study results and patient
experience will be consistent with study findings to date or that Amyvid will
prove to be commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States Securities
and Exchange Commission. Lilly undertakes no duty to update forward-looking
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Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
- 4 -
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Mirra SS, Heyman A, McKeel D, et al; and participating CERAD neuropathologists.
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD): part
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Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report:
2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8:131-168.
Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of
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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):
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.
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public health priority. http://whqlibdoc.who.int/publications/2012/
9789241564458_eng.pdf. Published 2012. Accessed November 15, 2012.
Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.