logo
Plus   Neg
Share
Email
Comment

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
Google plans to commission three underwater cables in 2019 as part of efforts to expand its cloud business amid stiff competition from rivals Microsoft and Amazon. The three fiber-optic subsea cables will run across different routes. Google noted that it has spent $30 billion to improve its infrastructure over three years. McDonald's Corp. said Tuesday that all of its packaging worldwide will come from renewable, recycled or certified sources by 2025, up from the current figure of 50 percent. The fast food giant also aims to recycle guest packaging in all its restaurants by then, compared with only 10 percent of its restaurants currently. General Electric Co. (GE) will take an after-tax charge of $6.2 billion in its fourth quarter results as part of comprehensive review of its finance arm's insurance portfolio. The after-tax charge will be $7.5 billion when adjusted to the rate following the recent U.S. tax overhaul.
comments powered by Disqus
Follow RTT