News | January 21, 2011

FDA Panel Recommends Conditional Approval for PET Agent

January 21, 2011 — The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided that it could not recommend approval of Amyvid (florbetapir) at this time based on the currently available data (13-3); but, voted unanimously (16-0) to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans. The committee said efficacy was established and there were no significant safety concerns raised.

Amyvid is an imaging tool indicated for positron emission tomography (PET) imaging of beta-amyloid plaque in the brain. It is being investigated for the potential use in ruling out Alzheimer's disease. In addition to the pivotal phase III "Image-to-Autopsy" study, other clinical studies are also being conducted in the European Union., North and South America, Australia and Asia. The committee stated that a negative scan would be clinically useful in indicating that Alzheimer's pathology is unlikely to be the cause of a patient's cognitive decline.

Lilly acquired Avid Radiopharmaceuticals Inc. in December 2010. Amyvid is Avid's lead candidate and was the first beta-amyloid imaging compound to enter multi-center, investigational new drug (IND) clinical studies in the United States. Amyvid was recently assigned priority review designation by the FDA.

The FDA will consider the panel's recommendation in its review of Amyvid. The FDA takes the advice of its advisory committees into consideration when reviewing investigational drugs, but is not bound by their recommendations.

For more information: www.lilly.com

Related Content

Fujifilm’s Sonosite SII POC ultrasound system helps to keep crowded areas clearer with a small ultrasound footprint.

Fujifilm’s Sonosite SII POC ultrasound system helps to keep crowded areas clearer with a small ultrasound footprint.

Feature | Ultrasound Imaging | July 07, 2020 | By Joan Toth
With the miniaturization of technology, improved ease of use, lower system cost, increased portability and greater ac
A patient implanted with the Axonics System can undergo MRI examinations safely with radio frequency (RF) Transmit Body or Head Coil under the conditions outlined in the Axonics MRI Conditional Guidelines.

A patient implanted with the Axonics System can undergo MRI examinations safely with radio frequency (RF) Transmit Body or Head Coil under the conditions outlined in the Axonics MRI Conditional Guidelines.

News | Magnetic Resonance Imaging (MRI) | July 02, 2020
July 2, 2020 — Axonics Modulation Technologies, Inc., a medical technology company that has developed and is commerci
This data represents wave 2 of a QuickPoLL survey conducted in partnership with an imagePRO panel created by The MarkeTech Group (TMTG), regarding the effects of COVID-19 on their business

Getty Images

Feature | Coronavirus (COVID-19) | July 01, 2020 | By Melinda Taschetta-Millane
A 3-D ultrasound system provides an effective, noninvasive way to estimate blood flow that retains its accuracy across different equipment, operators and facilities, according to a study published in the journal Radiology.

Volume flow as a function of color flow gain (at a single testing site). For each row the color flow c-plane and the computed volume flow are shown as a function of color flow gain. The c-plane is shown for four representative gain levels, whereas the computed volume flow is shown for 12–17 steps across the available gain settings. Flow was computed with (solid circles on the graphs) and without (hollow circles on the graphs) partial volume correction. Partial volume correction accounts for pixels that are only partially inside the lumen. Therefore, high gain (ie, blooming) does not result in overestimation of flow. Systems 1 and 2 converge to true flow after the lumen is filled with color pixel. System 3 is nearly constant regarding gain and underestimates the flow by approximately 17%. Shown are mean flow estimated from 20 volumes, and the error bars show standard deviation. Image courtesy of the journal Radiology

News | Ultrasound Imaging | July 01, 2020
July 1, 2020 — A 3-D ultrasound
Researchers reviewed results of prostate biopsies on over 3,400 men who had targets identified on prostate MRI and found that the positive predictive value of the test for prostate cancer was highly variable at different sites
News | Prostate Cancer | July 01, 2020
July 1, 2020 — Prostate MRI is an emerging technology used to identify and guide treatment for...
R2* maps of healthy control participants and participants with Alzheimer disease. R2* maps are windowed between 10 and 50 sec21. Differences in iron concentration in basal ganglia are too small to allow visual separation between patients with Alzheimer disease and control participants, and iron levels strongly depend on anatomic structure and subject age. Image courtesy of Radiological Society of North America

R2* maps of healthy control participants and participants with Alzheimer disease. R2* maps are windowed between 10 and 50 sec21. Differences in iron concentration in basal ganglia are too small to allow visual separation between patients with Alzheimer disease and control participants, and iron levels strongly depend on anatomic structure and subject age. Image courtesy of Radiological Society of North America

News | Magnetic Resonance Imaging (MRI) | July 01, 2020
July 1, 2020 — Researchers using magnetic...
Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for its head CT scan product qER. The US Food and Drug Administration's decision covers four critical abnormalities identified by Qure.ai's emergency room product.
News | Artificial Intelligence | June 30, 2020
June 30, 2020 — Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for
In new QuickPoLL survey on imaging during the pandemic, responses were tallied from around 170 radiology administrators and business managers, who are part of an imagePRO panel created by The MarkeTech Group (TMTG), regarding the effects of COVID-19 on their business. TMTG is a research firm specializing in the medical device, healthcare and pharmaceutical industries.
Feature | Coronavirus (COVID-19) | June 30, 2020 | By Melinda Taschetta-Millane