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

Quick Facts

Editors Pick
After ending the previous session mostly higher, stocks may see some further upside in early trading on Wednesday. The major index futures are currently pointing to a modestly higher open for the markets, with the Dow futures up by 17 points. The Bank of Spain on Wednesday boosted its growth projections for Spain this year and the next after the economy grew at a faster rate in the second quarter. In its monthly economic bulletin, the bank raised the growth forecast for this year to 1.3 percent from the 1.2 percent seen previously. The projection for the next year was lifted to 2 percent from 1.7 percent. Bank of England policymakers unanimously decided to maintain the key interest rate and quantitative easing at the meeting held on July 9 and 10, but signaled the possibility of a rate hike late this year as growth became more established.
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.