logo
Share SHARE
FONT-SIZE Plus   Neg

Eli Lilly Says FDA Oks Amyvid - Quick Facts

Eli Lilly and Co. (LLY) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The bench to bedside journey of drugs is fraught with challenges. It is estimated that only 5 in 5,000 compounds that enter preclinical testing make it to human testing, and out of those 5, only 1 may pass through all the regulatory hurdles needed to reach pharmacy shelves. Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions.
comments powered by Disqus
Follow RTT