This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Amyvid™ (Florbetapir F 18 Injection) Approved In European Union For Use In Patients With Cognitive Impairment Being Evaluated For Alzheimer's Disease And Other Causes Of Cognitive Impairment

INDIANAPOLIS, Jan. 15, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced today that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission 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 and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.[1]

Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging.[2],[3] Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms, including deficiencies in memory, visuospatial ability, executive function, behavior, and language.[2],[3]  It is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.[4],[5]

"We believe that Amyvid fills an unmet need in the medical community, providing physicians with important information about the presence or absence of beta-amyloid plaques that can help identify the cause of their patients' cognitive symptoms," said Diane Bakaysa, Amyvid global brand development leader. "This is important because, if, based on negative Amyvid findings and clinical assessment, it is determined that Alzheimer's Disease is not the cause of cognitive impairment, a physician can avoid unnecessary or potentially harmful treatments associated with a misdiagnosis of Alzheimer's Disease."[6],[7],[8]

Beginning in Q2 2013, Amyvid will be available in select areas within the European Union.

Amyvid for intravenous use was approved by the U.S. Food and Drug Administration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500–1,900 MBq/mL Florbetapir F 18.[9]  Amyvid is indicated 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 (AD) and other causes of cognitive decline.[9]

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. 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 AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.[9]

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,143.92 +12.06 0.07%
S&P 500 2,014.89 +15.91 0.80%
NASDAQ 4,839.0850 +0.4420 0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs