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U.S. FDA approves a radioactive compound for evaluating people with Alzheimer's disease
U.S.
FDA approves a radioactive compound for evaluating people with
Alzheimer's disease, another way nuclear medicine is helping to increase
the quality of life! http://www.prnewswire.com/news-releases/fda-approves-amyvid-florbetapir-f-18-injection-for-use-in-patients-being-evaluated-for-alzheimers-disease-and-other-causes-of-cognitive-decline-146497155.html
...""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."
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