Date: January 15, 2013
For Release: Immediately
Refer to: Celeste Stanley, +
317-478-0263 (mobile), stanley_celeste_a@lilly.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 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." ,
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 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.
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 needs. P-LLY
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 statements.
# # #
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
- 4 -
Amyvid [package insert]. European Union. Eli Lilly & Co.;
2013.
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.
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.
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 Alzheimer's disease in a community-based case
series. J Am Geriatr Soc. 1999;47 (5):564-569.
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.
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.
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.
Amyvid [package insert]. Indianapolis,
IN: Lilly USA, LLC;
2012.
