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:8/15/2017)... Inc. announced today that its fully owned USA ... York City Office in Yonkers, New York ... (TWO 2 ) homecare therapy. This new East Coast location has ... under the company,s DMEPOS accreditation for Home/Durable Medical Equipment Services. ... Advanced Oxygen Therapy Inc. New ...
(Date:8/8/2017)... 2017   Second-quarter ... (GAAP) loss per share from continuing operations ... increased 16 percent to $110 million ... percent to $161 million ... continuing operations increased 8 percent to $0.93 ...
(Date:8/7/2017)... -- Endo International plc (NASDAQ: ENDP ) today ... known U.S. mesh product liability claims and that it ... U.S. claims at reasonable values. Under the agreements, Endo ... of 2017 and continuing through the fourth quarter of ... the Company intends to increase its mesh product liability ...
Breaking Medicine Technology:
(Date:8/21/2017)... ... August 21, 2017 , ... San Diego physician and surgeon Dr. James Veltmeyer, ... announced his candidacy for the 52nd Congressional District currently held by Representative Scott Peters. ... to this country at age eleven after suffering homelessness and hardship in a distant ...
(Date:8/20/2017)... ... August 20, 2017 , ... A total solar eclipse will occur across ... minutes as the moon moves between the sun and Earth. This rare event will be ... tips can help keep you safe on the road during the total eclipse of the ...
(Date:8/20/2017)... ... August 20, 2017 , ... Are you an adult ... If so, you may be interested in participating in a research study that ... research is to understand more about the relational aspects of adults who have gluten ...
(Date:8/19/2017)... , ... August 18, 2017 , ... ... aimed at creating a transparent, verifiable database to help the cannabis industry move ... technology, Paragon hopes to deliver a faster technology with lower fees. Paragon will ...
(Date:8/19/2017)... Toronto, ON (PRWEB) , ... August 19, 2017 , ... ... of the of NaturallyCurly.com® The Curl Leaders, Editors’ Choice 2017 Award for the second ... must-have accessory for hair stylists and curlies alike was voted Best Moisturizer for Type ...
Breaking Medicine News(10 mins):