TIDMLEL
Date: April 6, 2012
For Release: Immediately
Refer to: Stefanie Prodouz, +1 317-224-5331, prodouzs@lilly.com
FDA Approves Amyvidtm (Florbetapir F 18 Injection) for Use in Patients Being
Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Amyvid is the first and only radioactive diagnostic agent approved for PET
imaging of beta-amyloid neuritic plaques in the living brain
INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals,
Inc., a wholly owned subsidiary of Lilly, today announced the U.S. Food and
Drug Administration (FDA) approval of Amyvidtm, 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. Amyvid binds to amyloid plaques, a hallmark characteristic
of Alzheimer's Disease,,, and is detected using PET scan images of the brain.1
A negative Amyvid scan indicates sparse to no amyloid plaques are currently
present, which is inconsistent with a neuropathological diagnosis of
Alzheimer's Disease and reduces the likelihood that a patient's cognitive
impairment is due to Alzheimer's Disease.2, A positive Amyvid scan indicates
moderate to frequent amyloid plaques are present; this amount of amyloid plaque
is present in patients with Alzheimer's Disease, but may also be present in
patients with other types of neurologic conditions and in older people with
normal cognition.1, 4,
It's important to note that Amyvid is an adjunct to other diagnostic
evaluations. A positive Amyvid scan does not establish a diagnosis of
Alzheimer's Disease, or other cognitive disorder. Additionally, the safety and
effectiveness of Amyvid have not been established for predicting development of
dementia or other neurologic condition, or monitoring responses to therapies.1
Alzheimer's Disease is one of several possible causes of cognitive decline.
Alzheimer's
Disease and other causes of cognitive impairment share many overlapping
symptoms including memory, visuospatial ability, executive function, behavior
and language deficiencies.4, Because a definitive diagnosis of Alzheimer's
Disease is usually determined upon autopsy, physicians rely on medical history,
clinical examination and a variety of diagnostic tools when evaluating
patients.4
"It's estimated that one in five patients clinically diagnosed with probable
Alzheimer's Disease during life do not end up having Alzheimer's Disease
pathology upon autopsy,", said Daniel Skovronsky, M.D., Ph.D., president and
CEO of Avid, and global brand development leader for Amyvid at Lilly. "The
approval of Amyvid offers physicians a tool that, in conjunction with other
diagnostic evaluations, can provide information to help physicians evaluate
their patients."
Amyvid was evaluated in three clinical studies that examined images from
healthy adult patients as well as patients with a range of cognitive disorders,
including some terminally ill patients who had agreed to participate in a
postmortem brain donation program. Based on the results of study one,
measurements of postmortem cortical amyloid burden correlated with median
Amyvid scores (r=0.78; P<0.0001). In the second study, using the majority
interpretation of five readers, Amyvid PET showed 96 percent sensitivity and
100 percent specificity in patients who received an Amyvid PET scan within one
year of death. Across all readers and all autopsied patients, Amyvid PET
demonstrated median sensitivity of 92 percent (range 69 percent to 95 percent)
and specificity of 95 percent (range 90 percent to 100 percent) for readers
trained in person (study two), and median sensitivity of 82 percent (range 69
percent to 92 percent) and specificity of 95 percent (range 90 percent to 95
percent) for readers trained using an electronic media-based training (study
three). Additionally, inter-reader reproducibility analysis for all images in
study three showed an overall Fleiss' kappa statistic of 0.83 (95 percent CI:
0.78 to 0.88). The most common adverse reactions reported in clinical trials
were headache (1.8 percent), musculoskeletal pain (0.8 percent), fatigue (0.6
percent), nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent),
increased blood pressure (0.4 percent), claustrophobia (0.4 percent), feeling
cold (0.4 percent), insomnia (0.4 percent) and neck pain (0.4 percent).1
"Florbetapir gives patients with cognitive decline, their families and the
physicians who treat them, more information about the amyloid plaques that may
be found in their brain," said R. Edward Coleman, M.D., professor of radiology,
Duke University Medical Center. "This approval marks a great advancement in
nuclear medicine practice, as it enables us to evaluate the presence or absence
of moderate to frequent levels of amyloid plaques in a patient's brain. In
conjunction with other tests, florbetapir may help give physicians additional
information when evaluating patients for the cause of their cognitive decline."
Because Amyvid loses over half of its radioactivity every two hours, Amyvid
must be distributed directly from a radiopharmacy to the imaging centers where
it will be administered within several hours. Beginning in June, a limited
number of radiopharmacies will be distributing Amyvid with the goal of making
the product available in more areas as soon as possible.
"The approval of Amyvid exemplifies Lilly's commitment to discovering and
developing innovative products for many of the world's unmet medical needs,"
said Alex Azar, president, Lilly USA. "We are working hard with our
manufacturing partners to increase production of Amyvid and will notify the
community as it becomes available in more markets."
Amyvid images should be interpreted only by readers who have successfully
completed Amyvid reader training. Lilly has worked collaboratively with the FDA
and nuclear medicine experts to identify the appropriate ways to support
accurate and consistent interpretation of Amyvid scans by imaging physicians.
These efforts resulted in the development and validation by Lilly of both an
online and in-person reader training program for physicians using Amyvid.
Errors may occur in the estimation of plaque density during image
interpretation.
About Amyvid
Amyvid is a radioactive diagnostic agent tagged with a radioisotope called
fluorine-18. Once Amyvid is injected into a vein, it travels through the
bloodstream and into the brain, binding to amyloid plaques. Amyvid produces a
positron signal, which is detected by a PET scanner and used to create a brain
image. A radiologist, who should have successfully completed Amyvid reader
training, then interprets the image to evaluate for the presence or absence of
significant amyloid plaques (i.e., moderate to frequent levels of neuritic
plaques) in the brain. This information is reported back to the referring
physician, who then determines the next steps in the evaluation and management
of the patient.
Indication and Important Safety Information About Amyvid
Indication
Amyvid is a radioactive diagnostic agent for 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 and other causes of
cognitive decline. A negative Amyvid scan indicates sparse to no neuritic
plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's
Disease at the time of image acquisition; a negative scan result reduces the
likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.
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 Alzheimer's Disease, 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.
Limitations of Use:
A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease,
or other cognitive disorder. Additionally, the safety and effectiveness of
Amyvid have not been established for predicting development of dementia or
other neurologic condition, or monitoring responses to therapies. 1
Amyvid is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing
500-1900 MBq/mL florbetapir F 18.
Important Safety Information
Warnings and Precautions:
Risk for Image Misinterpretation and other Errors
Errors may occur in the Amyvid estimation of brain neuritic plaque density
during image interpretation.
Image interpretation should be performed independently of the patient's
clinical information. The use of clinical information in the interpretation of
Amyvid images has not been evaluated and may lead to errors. Other errors may
be due to extensive brain atrophy that limits the ability to distinguish gray
and white matter on the Amyvid scan as well as motion artifacts that distort
the image.
Amyvid scan results are indicative of the brain neuritic amyloid plaque content
only at the time of image acquisition and a negative scan result does not
preclude the development of brain amyloid in the future.
Radiation Risk
Amyvid, similar to other radiopharmaceuticals, contributes to a patient's
overall long-term cumulative radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk of cancer. Ensure safe handling
to protect patients and health care workers from unintentional radiation
exposure.
Most Common Adverse Reactions
The most common adverse reactions reported in clinical trials were headache
(1.8 percent), musculoskeletal pain (0.8 percent), fatigue (0.6 percent),
nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent), blood
pressure increased (0.4 percent), claustrophobia (0.4 percent), feeling cold
(0.4 percent), insomnia (0.4 percent) and neck pain (0.4 percent).
Drug Interactions
Pharmacodynamic drug-drug interaction studies have not been performed in
patients to establish the extent, if any, to which concomitant medications may
alter Amyvid image results.
For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf.
AM HCP ISI 06APR2012
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. Additional information about Lilly is available at www.lilly.com.
This press release contains certain forward-looking statements about Amyvidtm, 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 the product
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.
©Lilly USA, LLC 2012. All rights reserved. AM76164
Amyvidtm is a trademark of Eli Lilly and Company
P-LLY
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
Amyvid Prescribing Information. April 6, 2012.
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