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Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)
Date:7/10/2009

ote&Ticker=LLY'> LLY) co-developed Effient, which was discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. (TSE: 4208).

TRITON-TIMI 38 CLINICAL TRIAL

The approval was based on results from the pivotal Phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with Plavix(R) (clopidogrel bisulfate) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19 percent relative risk reduction of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as three days and continued over the 15 months of the trial. In addition, there were fewer stent-related clots (known as stent thrombosis) in patients treated with Effient compared with Plavix (a relative risk reduction of approximately 50 percent).

The risk of non-coronary artery bypass graft (non-CABG) related bleeding, which included life-threatening and fatal bleeding, was significantly higher with Effient (2.2 percent) compared with Plavix (1.7 percent). When compared with the overall treatment population, the risk of major bleeding was highest among those patients treated with Effient who were either 75 years or older, had a body weight less than 132 pounds, or had a prior history of transient ischemic attack/stroke.

An analysis from TRITON-TIMI 38, weighing the risk of major bleeding and the reduction in cardiovascular events, found an overall benefit significantly favoring Effient compared with Plavix. For every 1,000 patients treated with Effient as compared with Plavix, there were 23 fewer patients with heart attacks and six more with major bleeding events.

In addition, the results from a pharmacogenetic subst
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SOURCE Eli Lilly and Company
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