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

patients who weigh less than 132 pounds (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 mg to 325 mg aspirin orally once daily, according to their doctors' instructions.

"The data from the TRITON-TIMI 38 Phase 3 pivotal trial provide compelling evidence that treatment with prasugrel significantly reduced the combined risk of cardiovascular death, heart attack or stroke over the current standard of care, clopidogrel, across a wide variety of patient types," said lead TRITON-TIMI 38 investigator Elliott Antman, M.D., professor of Medicine at Brigham and Women's Hospital (BWH) in Boston and senior investigator with the BWH TIMI Study Group. "Prasugrel is an important new option for patients with ACS who are managed with PCI. Prasugrel was associated with a significantly higher risk of serious bleeding events compared with clopidogrel. However, appropriate patient selection may help reduce this risk."

The risk of bleeding was highest in Effient-treated patients who were either 75 years of age or older, weighed less than 132 pounds (60 kg), or who had a prior history of transient ischemic attacks (TIA) or stroke. Effient is contraindicated in patients with a history of prior TIA/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of prior heart attack.

ACS, which includes heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually, many of whom are managed with PCI(i). In 2009, an estimated 785,000 people in the United States will have a new heart attack and about 470,000 will have a recurrent attack.(ii)

Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: '/>"/>

SOURCE Eli Lilly and Company
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