If Approved for Marketing in the United States, Trade Name Will be
TOKYO and INDIANAPOLIS, Jan. 4 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA). Prasugrel is an oral antiplatelet agent, initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting.
If approved for marketing in the United States, the trade name for prasugrel will be Effient(TM), company officials added.
"We are elated," said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008. The benefit/risk profile of this compound, in comparison with the current standard of care, has the potential to improve outcomes for ACS patients undergoing PCI."
The NDA is based upon data from several trials, including the landmark
TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of
prasugrel compared with clopidogrel (Plavix(R)/Iscover(R)) in reducing
ischemic events such as non-fatal heart attack, non-fatal stroke and
cardiovascular death in 13,608 patients. In the study, treatment with
prasugrel resulted in a:
-- 19 percent relative risk reduction compared with clopidogrel in all ACS
patients in the primary composite endpoint of non-fatal heart atta
|SOURCE Eli Lilly and Company|
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