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

Editors Pick
J.M. Smucker Co. Tuesday announced a voluntary recall of some shipments of dog food, including Gravy Train, Kibbles 'N Bits, Ol' Roy, and Skippy canned/wet dog food, after finding "extremely low levels" of pentobarbital. Pentobarbital is a barbiturate drug that is most commonly used in animals as... Amazon.com Inc. (AMZN) Tuesday announced that its Prime members can earn 5% back on Whole Foods Market purchases when using Amazon Prime Rewards Visa Card. With this latest discount offer, Amazon Prime members who shop using the Amazon Prime Rewards Visa Card now enjoy 5 percent back on Whole Foods... Lucky Charms' new marshmallow - the magical unicorn is ready to attract kids and cereal lovers. This is the first marshmallow to be introduced in the last ten years.
comments powered by Disqus
Follow RTT