logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
An administrative law judge has ruled that Minnesota regulators should approve Enbridge Inc.'s proposal to replace its aging Line 3 crude oil pipeline only if the company follows the existing route and not its preferred route. Enbridge has applied to replace its Line 3 pipeline from Alberta with new pipe along its existing route. In Minnesota, the planned route deviates from the existing route. CLICK HERE to see America's 10 Best-Selling Drugs Despite high drug costs, most of the top-selling drugs saw sales gains in 2017 compared to the prior year. A large number of the best-selling drugs are primarily for the treatment and management of cancer, diabetes, inflammatory disorders, and HIV... Most Americans have access to health care, though costs and services vary from state to state. However, higher costs do not necessarily translate into better results. The U.S. continues to be outperformed by other wealthy nations on several measures like life expectancy, disease burden and health...
Follow RTT