Prasugrel Approved in Europe as Efient

February 23, 2009—Daiichi Sankyo Company, Ltd (Tokyo, Japan) and Eli Lilly and Company (Indianapolis, IN) announced that the European Commission has granted marketing authorization for Efient (prasugrel) for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). A market release is expected shortly, the companies stated. According to Daiichi Sankyo and Eli Lilly, Efient was superior to clopidogrel in reducing the risk of major cardiovascular events (combined endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in ACS patients undergoing PCI, as found in the TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38) phase 3 study. The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency on December 18, 2008. The companies stated that the committee's opinion was based on its review of several clinical trials, including TRITON-TIMI 38, which evaluated the safety and efficacy of prasugrel compared with clopidogrel in reducing atherothrombotic events in 13,608 patients with ACS undergoing PCI. TRITON-TIMI 38 was published by Stephen D. Wiviott, MD, et al in The New England Journal of Medicine in November 2007 (2007;357:2001-2015) The trial showed that prasugrel taken with aspirin was superior to clopidogrel taken with aspirin in reducing the relative risk of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients with ACS undergoing PCI, by 19% (observed rates of 9.4% vs 11.5%, respectively). Prasugrel also reduced the risk of stent-related clots by 50% when compared with clopidogrel, the companies stated.