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Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
Date:2/3/2009

in Boston and senior investigator with BWH's TIMI Study Group. "In a large head-to-head trial, TRITON, showed that prasugrel was superior to clopidogrel, the current standard of care. While the benefit of prasugrel is accompanied by an increased risk of serious bleeding events, appropriate selection of patients and doses may help mitigate this risk."

The committee reviewed comprehensive data primarily from the TRITON TIMI- 38 clinical trial. Results from the TRITON trial showed that prasugrel taken with aspirin reduced the relative risk of the combined endpoint of cardiovascular death, non-fatal heart attacks or non-fatal stroke by 19 percent more than clopidogrel (Plavix(R)/Iscover(R)) taken with aspirin. These benefits were accompanied by an increased risk of serious bleeding with prasugrel overall, some of which included life-threatening and even fatal bleeding. When the risk of this type of bleeding was compared to the benefit of reduced heart attack, there were five more TIMI major bleeding events, but 22 fewer heart attacks for every 1,000 patients treated with prasugrel compared to every 1,000 patients treated with clopidogrel.(i) The overall risk of cardiovascular death and the risk of increased stroke were not statistically different between treatment groups.

FDA reviewers will consider the panel's favorable recommendation in its review of the new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo, Limited, on December 26, 2007.

The Burden of Acute Coronary Syndromes

Acute coronary syndromes (ACS), which includes heart attack and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(ii) Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(iii) Coronary artery disease
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SOURCE Eli Lilly and Company
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