Navigation Links
Lilly and Avid Receive Complete Response Letter from FDA for Amyvid™ (florbetapir F 18 injection)
Date:3/18/2011

INDIANAPOLIS and PHILADELPHIA, March 18, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the U.S. Food and Drug Administration (FDA) for their New Drug Application (NDA) for Amyvid™ (florbetapir F 18 injection), a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.

The complete response was primarily focused on the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.

"Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA," said Wei-Li Shao, Lilly brand director for Amyvid. "We remain confident in the data submission package for Amyvid."

Since questions on the reader training program were raised by FDA reviewers late last year, Lilly and Avid have been working to address these questions and will continue to do so in an ongoing dialogue with the FDA.

About Amyvid™ (florbetapir F 18 injection)

Amyvid is a molecular imaging agent under investigation for PET imaging of beta-amyloid plaque in the brain.  Clinical studies for Amyvid are 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 F 18 injection) for use as a molecular imaging tool for the detection of β-amyloid (beta-amyloid) plaque in the brains of living patients. 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 Amyvid 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. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
3. Lilly and Glenmark Pharmaceuticals Announce License Agreement
4. Lilly Receives NCQA Design Certification for Depression Care Management Program
5. JDRF and Lilly Partner to Fund Research to Identify Beta Cell Biomarkers
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
8. Lilly and Transition Therapeutics Announce Licensing and Collaboration Agreement
9. Lilly Launches Its First Phase III Trial for Treatment of Alzheimers Disease
10. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
11. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... CRANBURY, N.J. , Feb. 12, 2016  Innophos Holdings, ... performance-critical and nutritional specialty ingredients, today announced that it will ... at 10:00 am ET to discuss its fourth quarter and ... --> The press release detailing fourth quarter and ... 2016 after market close. --> ...
(Date:2/12/2016)... , Feb. 12, 2016  SI-BONE, Inc., a medical device company ... ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for ... Services, Inc. (NGS), the Medicare Administrative Contractor (MAC) covering the states ... Maine , Massachusetts , ... New York , Rhode Island , ...
(Date:2/12/2016)... -- On Thursday, Feb. 11, 2016, surgeons at the ... Austin Medical Center successfully completed the first robotic surgery ... Surgical System with Trumpf Medical,s advanced operating table, the ... M.D., colorectal surgeon at the Texas Institute for Robotic ... technology, which seamlessly combines the da Vinci Xi Surgical ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... 13, 2016 , ... The producers of Enterprises TV are pleased ... increasingly modern world of instantaneous consumption proves very convenient for businesses. With new technologies ... and coal, which pollutes our air, water, and soil. It can also threaten the ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi , a Makro ... list for its expertise in eClinical Solutions. DDi has built its solution competency ... needs of global clients. DDi provides smarter technology for Clinical Development, Regulatory and ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... to funding innovative lymphoma research and serving the lymphoma community through a comprehensive ... members of South Florida’s philanthropic community at its 10th anniversary Fashion Luncheon on ...
(Date:2/12/2016)... California (PRWEB) , ... February 12, 2016 , ... Coco ... their participation in Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco Libre will ... way to stay hydrated before the big event. The invitation-only gifting suite, held this ...
(Date:2/12/2016)... ... February 12, 2016 , ... Fisher House Foundation Chairman and ... J. Lee, Nevada Military Support Alliance president Scott Bensing, and Peggy Kearns Director, VA ... Southern Nevada Healthcare System. This will be the first Fisher House in Nevada, ...
Breaking Medicine News(10 mins):