Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Admi... (ck non-fatal stroke or cardiovascu...)

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Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration

Date:1/4/2008

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non-fatal stroke or cardiovascular death (p<0.001).

-- 52 percent reduction compared with clopidogrel in stent thrombosis

(p<0.0001).

-- 30 percent relative risk reduction compared to clopidogrel in a subset

of patients with diabetes (p<0.001) on the composite endpoint of non-

fatal heart attack, non-fatal stroke, or cardiovascular death.

Risk reductions in the primary composite endpoint with prasugrel compared to clopidogrel were seen as early as three days and continued to diverge for 15 months (the duration of the trial.)

Though the incidence of non-coronary artery bypass grafting(non-CABG) bleeding in TRITON was low in both the prasugrel and clopidogrel treatment groups, prasugrel-treated patients experienced significantly higher non-CABG major bleeding (2.2% vs. 1.7%, respectively) and higher rates of life- threatening bleeding (1.3% vs. 0.8%, respectively). Death from cardiovascular causes (2% vs. 2.2%, respectively) and all-cause death (2.8% vs. 2.9%, respectively) was comparable among prasugrel-treated patients and clopidogrel- treated patients. The overall results demonstrated that for every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more non-CABG-related TIMI major bleeds.

"Given the overall results from TRITON, this submission is particularly meaningful considering that cardiovascular disease is the leading cause of death in the United States and worldwide, killing 16.7 million people each year," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

Acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 840,000 Americans each year and 800,000 people in Europe.(i,ii) Utilizing current medical interventions and treatments, 300,000 people continue to experience recurrent heart attacks and 450,000 people die fro
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Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Admi...(ck non-fatal stroke or cardiovascu...)