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:6/14/2017)... 2017  In 2016, Embodied Labs took ... competition and came away with $25,000 in seed-fund investment. ... Forbes as "entering the life of another" and by ... "empathy to medical professionals in an entirely new dimension." ... a finalist for the Department of Education,s EdSimChallenge, where ...
(Date:6/9/2017)... 9, 2017 AirXpanders, Inc. (ASX: AXP) (AirXpanders ... design, manufacture, sale and distribution of the AeroForm® Tissue ... of its commercial roll-out in the United ... than one hundred (100) medical institutions and health systems, ... a needle-free alternative for women who choose reconstructive surgery ...
(Date:6/7/2017)... , June 7, 2017 Endo International ... June 7, 2017, the Hon. Joseph R. Goodwin ... of West Virginia , entered a ... Inc. Pelvic Repair System Products Liability Litigation (the "MDL") ... MDL cases to provide expert disclosures on specific causation ...
Breaking Medicine Technology:
(Date:6/24/2017)... ... June 24, 2017 , ... The Pennsylvania Athletic Trainers’ ... Bayfront and Erie Convention Center on June 8-10. The weekend consisted of ... bowl, award and scholarship presentations, and professional networking. , On Friday June ...
(Date:6/24/2017)... TX (PRWEB) , ... June 24, 2017 , ... The ... to spend time outdoors. Home and business owners should be aware that the summer ... the lake. In fact, mechanical locks and keys can be negatively affected from direct ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... Network today announced the launch of Care Management Alerts and Dashboards, an innovative ... patients throughout Rhode Island. , RIQI’s Care Management Alerts and Dashboards provide near ...
(Date:6/23/2017)... ... June 23, 2017 , ... By scoring 100% for ... consecutive four-star rating from premier online charity evaluator, Charity Navigator, validating ANRF's work as ... of all charities reviewed by Charity Navigator and earns ANRF a spot on their ...
(Date:6/23/2017)... ... , ... Studies show evidence that carotenoids and antioxidants derived either from the ... patients. , But how often do ophthalmologists and optometrists in Sweden recommend the use ... or with early symptoms of AMD? A study published recently in Dove ...
Breaking Medicine News(10 mins):