Date: October 19, 2012
For Release: Immediately
Refer to: Morry Smulevitz +1
(317) 457-3294 (mobile), smulevitzmb@lilly.com
Maya Robotti +1 (347) 446-1208
(mobile), mrobotti@chamberlainpr.com
Amyvid (Florbetapir 18F) Solution for Injection Recommended for Approval in
Europe as a Diagnostic Tool for Imaging Beta-Amyloid Plaques - a Common
Neuropathological Feature of Alzheimer's Disease
Milestone reflects Eli Lilly and Company's commitment to bring
new diagnostic tool to physicians evaluating patients' cognitive decline
INDIANAPOLIS - Eli Lilly and
Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly
owned subsidiary of Lilly, today announced a positive opinion from
the Committee for Medicinal Products for Human Use (CHMP) in
Europe. The CHMP recommended
approval of 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.
A negative scan indicates sparse or no plaques, which is not
consistent with a diagnosis of AD.
A positive scan 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). Additional limitations exist for use in patients
with mild cognitive impairment (MCI) and are included in the
label.
Image interpretation errors in the estimation of brain
beta-amyloid neuritic plaque density, including false negatives,
have been observed. Amyvid images should only be interpreted by
readers trained in the interpretation of PET images with
florbetapir (18F). The efficacy of Amyvid for predicting
development of AD or monitoring response to therapy has not been
established.
The positive opinion is now referred for final action to the
European Commission, which has the authority to approve medicines
for the European Union (EU). The Commission usually decides on CHMP
recommendations within three months.
"The potential benefit of an Amyvid scan is that it enables
physicians to assess the density of beta-amyloid plaques in the
brain," said Diane Bakaysa, Amyvid
global brand leader. "If approved by the European Commission,
Amyvid used in conjunction with a clinical evaluation may provide
valuable information for doctors when evaluating patients suspected
of having Alzheimer's disease or other causes of cognitive
decline."
Confirming the absence or presence of beta-amyloid plaques in
patients being evaluated for AD and other causes of cognitive
impairment is important because there are many causes of cognitive
impairment, including AD, neurological disorders, blood
vessel-related disorders causing vascular dementia, movement
disorders, such as Parkinson's and Huntington's diseases, brain tumors, normal
pressure hydrocephalus, traumatic brain injury and infections such
as HIV.
The positive opinion 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 subsequently had neuropathological evaluation
of beta-amyloid deposition in the brain post-mortem. 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). In a study of 47 young (<40 years), healthy
volunteers, presumed to be free of beta-amyloid, all Amyvid PET
scans were negative.
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.
Amyvid was approved by the United
States (U.S.) Food and Drug Administration (FDA) for use in
the U.S. in April 2012.
About Alzheimer's Disease
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. Researchers do not know exactly what
causes AD and there are currently no approved treatments shown to
slow the progression of this devastating disease, only treatment
options that reduce certain symptoms of the disease.2 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.
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.
This press release contains forward-looking statements about the
potential of Amyvid. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in
the process of development, commercialization and regulatory
review. There is no guarantee that the product will receive
additional regulatory approvals. There is also no guarantee that
Amyvidwill continue 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.
P-LLY
###
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
- 3 -
National Institute of Neurological Disorders and Stroke.
"Dementia: Hope Through Research." Available at:
http://www.ninds.nih.gov/disorders/dementias/ detail_dementia.htm
#1908919213. Accessed on October 18,
2012.
Thies W, Bleiler L; Alzheimer's Association. Alzheimer's
Association report: 2012 Alzheimer's disease facts and figures.
Alzheimers Dement. 2012;8:131-168.
Alzheimer's Disease International, World Health Organization.
Dementia: a public health priority. Available at:
http://whqlibdoc.who.int/publications/ 2012/9789241564458_eng.pdf.
Published 2012. Accessed on October 18,
2012.
