European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Unde...(es a new antiplatelet option for treatin...)

In a large Phase III study, prasugrel was superior to Plavix(R)/Iscover(R) (clopidogrel) in reducing the risk of suffering major cardiovascular events (combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke) in ACS patients undergoing PCI. The risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg (132 lbs), patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. Patients who weighed less than 60 kg, or were 75 years of age or older had increased exposure with prasugrel.

The U.S. Food and Drug Administration is evaluating whether prasugrel should be approved in the United States for the treatment of patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI). The proposed name for prasugrel in the US is Effient(TM).

Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd. (TSE:4208) as a treatment initially for patients with acute coronary syndromes who are undergoing PCI.

About Acute Coronary Syndrome

Acute coronary syndrome includes heart attacks and unstable angina (chest pain). 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.(1) In addition, ACS affect
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