Marketing Authorization Application (MAA) submission of Prasugrel
TOKYO, Japan, and INDIANAPOLIS, Ind. (February 20, 2008) – DAIICHI SANKYO Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) announced that they submitted in early February a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in London seeking approval to market prasugrel within the European Union for the prevention of atherothrombotic events in patients with acute coronary syndrome managed with percutaneous coronary intervention (PCI). A New Drug Application (NDA) for prasugrel was submitted to the U.S. Food and Drug Administration (FDA) on Dec. 26, 2007.
The MAA submission 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 in reducing atherothrombotic events (combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke) in 13,608 patients with acute coronary syndrome managed with PCI. These data were presented at the American Heart Association Scientific Sessions and simultaneously published online in The New England Journal of Medicine in November 2007.
"This EMEA submission for prasugrel represents a significant step toward achieving regulatory approval to make this important new treatment option available for patients throughout Europe,” said John Alexander, M.D., M.P.H., global head of research and development, DAIICHI SANKYO Company, Limited. “Cardiovascular disease remains the leading cause of death worldwide, and we are committed to making important new therapies available to improve patient outcomes.”
Cardiovascular disease kills 16.7 million people each year, and acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 800,000 people in Europe each year.1,2
About Prasugrel
DAIICHI SANKYO Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent discovered by DAIICHI SANKYO and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome who are managed with PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.
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1 American Heart Association. Heart Disease and Stroke Statistics - 2006 Update. Dallas, TX. American Heart Association.
2 Bertrand CURE study
