Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug A... ( TOKYO and INDIANAPOLIS Oct. 16 /-...)

Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application

Date:10/16/2008

TOKYO and INDIANAPOLIS, Oct. 16 /PRNewswire-FirstCall/ -- In response to recent media speculation regarding the status of the prasugrel new drug application (NDA), Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) reiterated today that they continue to have discussions with the FDA regarding the review of this application. The companies have not been notified of any regulatory action for the new drug application (NDA) or of any decision to have an advisory committee to review prasugrel. Prasugrel is an investigational antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), which is usually followed by the placement of a stent to help keep the artery open.

"Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA," said Jennifer Stotka, M.D., Lilly vice president of Global Regulatory Affairs. "We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to ACS patients, a population at risk for further cardiovascular events."

"The FDA can schedule an Advisory Committee at any time during the review of an application. If one is called, then we will be prepared to participate," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a new drug application to the FDA for prasugrel in December 2007. Lilly, on behalf of the alliance, also submitted a Marketing Authorization Application for prasugrel to the European Medicine
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine technology :

1. Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
2. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
3. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
4. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
5. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
6. Lilly and Deciphera Pharmaceuticals Announce Licensing and Collaboration Agreement
7. Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimers Disease Compound
8. Insulin Analogues From Novo Nordisk, Eli Lilly and Sanofi-Aventis Will Drive Growth in the Type 1 Diabetes Drug Market
9. Phase II Data on Lillys Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimers Disease
10. Lilly and TransPharma Medical Announce Licensing and Development Agreement
11. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration

Post Your Comments:

Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug A...( TOKYO and INDIANAPOLIS Oct. 16 /-...),Health