FDAnews
www.fdanews.com/articles/63462-daiichi-sankyo-presents-data-on-new-antiplatlet-drug

DAIICHI SANKYO PRESENTS DATA ON NEW ANTIPLATLET DRUG

October 24, 2006

Researchers with Japan-based Daiichi Sankyo have presented data from a Phase I study in which a 60-mg loading dose of the company's investigational antiplatelet compound prasugrel showed faster onset of activity and achieved greater inhibition of platelet aggregation than either the approved 300-mg loading dose of Plavix (clopidogrel) or a higher 600-mg Plavix dose.

Thirty minutes after oral administration, the level of platelet inhibition with a prasugrel was significantly higher than observed with either dose of clopidogrel. At one hour, the antiplatelet inhibition achieved with prasugrel was greater than that seen at up to six hours following administration of Plavix.

Daiichi Sankyo and partner Eli Lilly are also currently studying prasugrel in the Phase III head-to-head clinical trial, TRITON-TIMI 38. The study will evaluate the safety and efficacy of prasugrel compared with Plavix in reducing ischemic events such as heart attacks, stroke and death in approximately 14,000 patients with acute coronary syndrome undergoing percutaneous coronary intervention, including coronary stenting. Prasugrel is designed to inhibit platelet activation and aggregation by blocking the P2Y12 adenosine diphosphate receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can cause formation of blood clots and lead to heart attack or stroke.