logo
Share SHARE
FONT-SIZE Plus   Neg

Eli Lilly Says FDA Oks Amyvid - Quick Facts

Eli Lilly and Co. (LLY: Quote) 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
Apple Inc. said Tuesday after the markets closed that its first quarter profit rose 38% from last year, driven by all time record revenue from iPhone and Mac sales as well as record performance of its App Store. The company's quarterly earnings per share also breezed past Wall Street expectations as did its quarterly sales. We are just a few weeks into 2015 and it has already been a busy year for merger deals and merger talks. Here is a list of some of the M&A stories that have made headlines so far in 2015. Diversified electronics maker TE Connectivity Ltd. is nearing a deal to sell its network solutions business unit to CommScope Holding Co., Inc. (COMM) in a deal valued at about $3 billion, according a Wall Street Journal report on Monday. A deal could be announced as early as this week. There has...
comments powered by Disqus
Follow RTT