Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Eli Lilly Says FDA Oks Amyvid - Quick Facts

Eli Lilly and Co. (LLY: Quote) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly, announced the U.S. Food and Drug Administration, or FDA, approval of 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.

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. Meanwhile, a positive Amyvid scan indicates moderate to frequent amyloid plaques are present.

Amyvid was assessed 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 take part in a postmortem brain donation program. On the basis of 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.

Register
To receive FREE breaking news email alerts for Eli Lilly And Co. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Oracle Corp. said Wednesday after the markets closed that its second quarter profit fell 2% from last year, hurt mainly by higher income tax expenses even as revenue increased 3%. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. Apple's iPhone-based Apple Pay system is gaining momentum nationwide with a host of new banks and retailers signing on. The system allows users to link a credit card directly to their device for payments and Apple now says they have deals with banks that account for 90 percent of the debit card transactions in the US. The current drop in fuel prices could lead to a major sales dip for electric automaker Tesla, according to some industry experts. The Elon Musk led manufacturer had predicted sales of over 500,000 new vehicles by 2020, but now that number could fall by as much as 40 percent.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.