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
The parent company of Malaysia Airlines has decided to trim nearly one-third of its workforce as part of a recovery plan. Khazanah Nasional Berhad, the Malaysian Government's strategic investment fund, announced on Friday a 12-point Recovery Plan to revive Malaysian Airlines. A 30 percent staff reduction means about 6000 employees of the aviation company will become redundant. However, Khazanah Germany's unemployment increased unexpectedly in August as worsening economic activity weighed on job creation. In addition, consumer price inflation, at a four-and-a-half-year low, boosted the scope for more stimulus from the European Central Bank. The number of people out of work increased by a seasonally adjusted 2,000 persons to 2.901 million in August, the Federal Labor Agency reported. NASA has approved the development of the world's most powerful rocket, designed to take humans beyond Earth orbit and to Mars. NASA officials Wednesday announced they have completed a rigorous review of the Space Launch System (SLS) -- the heavy-lift, exploration class rocket under development - and approved the program's progression from formulation to development, something no other exploration
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.