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
Walt Disney Co. (DIS) is reportedly in talks to buy a stake in Major League Baseball Advanced Media. According to LA Times, citing people with knowledge of the matter, Disney is seeking to acquire one-third interest in the MLB.com, which develops and manages the league's digital products. The deal... Postal Savings Bank of China, one of the biggest banks in China, seeks to raise about $8 billion in an initial public offering, which could be the biggest IPO of the year. Postal Savings Bank of China plans to list its stock in the Hong Kong stock exchange. According to reports, the Postal Savings... Sporting goods retailer Dick's Sporting Goods, Inc. has emerged as the successful bidder in the bankruptcy auction for its former rival Sports Authority Holding Inc.'s intellectual property assets and the right to acquire 31 store leases.
comments powered by Disqus
Follow RTT