Navigation Links
Statement from Lilly and Avid on FDA Advisory Committee Recommendation for Amyvid™ (Florbetapir) NDA
Date:1/20/2011

INDIANAPOLIS and PHILADELPHIA, Jan. 20, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided today 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 supported that efficacy was established and there were no significant safety concerns raised.

Amyvid is a molecular imaging tool under investigation for the detection of beta-amyloid plaque in the brain. 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.

"We appreciate the careful and thoughtful review of our data today by the Committee," said Daniel M. Skovronsky, M.D., Ph.D., CEO, Avid Radiopharmaceuticals, Inc. "We are encouraged that they recommended a clear path toward approval."

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.

About Amyvid

Amyvid is an imaging tool indicated for Positron Emission Tomography (PET) imaging of beta-amyloid plaque in the brain. It's 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 E.U., North and South America, Australia and Asia.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.  Additional information about Lilly is available at www.lilly.com.  

P-LLY

This press release contains forward-looking statements about Amyvid (Florbetapir) for use as a molecular imaging tool for the detection of beta-amyloid plaque in the brain. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that florbetapir will be approved by the FDA on the anticipated timeline or at all, or that that it, will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO)


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. American Scientific Resources, Inc. Announces S-1 Registration Statement Effective; Commences Public Reporting Requirements
2. Statement From Lilly on FDA Advisory Committee Recommendation Regarding Liprotamase New Drug Application for Treatment of Exocrine Pancreatic Insufficiency
3. ThermoGenesis Corp. Files Shelf Registration Statement on Form S-3
4. Statement of Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management, Boston Scientific on JAMA Article
5. Cannabis Science Files Preliminary 14c Information Statement, the Action is to Create a New Class of Common Stock and Issue Dividend
6. PhRMA Statement on Department of Homeland Security Efforts to Crack Down on Counterfeiting Crimes
7. Lilly Statement Regarding President Obamas Meeting With U.S. Business Leaders
8. AcelRx Pharmaceuticals Files Registration Statement for Proposed Initial Public Offering
9. ERT Files Shelf Registration Statement
10. Ambit Biosciences Files Registration Statement for Proposed Initial Public Offering
11. Abbott Statement: Abbott Provides Support for Cholera Relief Efforts in Haiti
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... 3, 2016 BioNovus Innovations LLC and ... Advancing Medical Innovation (IAMI) today announced a new ... and medical devices. An agreement between ... to license, develop and commercialize medical innovations advanced ... "This partnership represents a significant advance in our ...
(Date:5/3/2016)... May 3, 2016  As a teenager, an active ... fever, which damaged his heart. He continued enjoying sports ... June 2013, Shepherd,s heart was giving out and he ... June 20, 2013, the Mesa, Arizona ... (TAH-t). Like a heart transplant, the SynCardia TAH-t is ...
(Date:5/3/2016)... , May 3, 2016  While you may be familiar with watching a film or ... also known as ultra-high-definition or 8MP in the Medical Industry.  Ampronix  is a renowned authorized ... innovative technology. Photo - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... 04, 2016 , ... A new collaboration will give more researchers access to ... (DCRI) and analytics leader SAS will provide researchers worldwide with data management and analytics ... Health System. , The DCRI and SAS share the goal of greater transparency ...
(Date:5/4/2016)... ... May 04, 2016 , ... Slepkow Slepkow & Associates, ... of the top website design companies to create a state of the art ... the law firm's main practice areas. These practice areas include: real estate, estate ...
(Date:5/4/2016)... ... 04, 2016 , ... Francesca Loparco, Co-Founder of Queen City Dream Cars, an ... same-day LASIK procedure at Christenbury Eye Center. The entrepreneur struggled with her computer, ... the same day as her in-office consultation and eye exam. Francesca’s eyesight was restored ...
(Date:5/4/2016)... ... May 04, 2016 , ... Advanced Spine & Sport ... restore its patients’ health, is hosting a free seminar on stem cell injections. The ... at Advanced Spine & Sport, 4601 Telephone Road, Suite 110, Ventura, CA. There are ...
(Date:5/4/2016)... , ... May 04, 2016 , ... ... 2016, a powerful cellular therapy software application that helps blood and marrow ... patients. , Since Transtem’s initial launch, Mediware has continued to enhance core application ...
Breaking Medicine News(10 mins):