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
|SOURCE Eli Lilly and Company|
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