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
Reserve Bank of Australia Governor Glenn Stevens kept the foreign exchange intervention plan open to build up confidence and bring the stubbornly high currency to lower levels."The exchange rate, another channel through which monetary policy usually has an effect, is probably not doing as much as it might usually be expected to do in achieving balanced growth," he said in his opening statement. Stocks turned in another strong performance during trading on Tuesday, extending the upward trend seen over the past several sessions. The gains on the day once again lifted the tech-heavy Nasdaq to a new fourteen-year closing high. President Barack Obama revealed Monday that he is dispatching Attorney General Eric Holder to Ferguson, Missouri, amid ongoing violence in the St. Louis suburb. Obama said Holder will travel to Ferguson on Wednesday to meet with the FBI agents and Justice Department personnel conducting an investigation of the shooting death of Michael Brown.
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.