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 U.S. Consumer Products Safety Commission has asked Safety 1st to recall 35,000 highchairs after several children fell and were injured. The recall covers about 35,000 wooden Safety 1st highchairs in three models: HC144BZF (Casablanca), HC229CZF (Gentle Lace) and HC229CYG (Black Lace). Safety... Ferrari, the luxury car division of Fiat Chrysler Automobiles (FCAU) is reportedly getting a much higher valuation than previously expected driven by its premium status of manufacturing high-performance luxury cars. According to reports, Ferrari expects the IPO to bring its market valuation to about... SeaWorld Entertainment Inc. (SEAS) has received another blow to its business as the California Coastal Commission banned breeding of captive killer whales in San Diego. The new law means SeaWorld won't be allowed to breed captive orcas, including through artificial insemination, at its California...
comments powered by Disqus
Follow RTT