EFFIENT Receives European Approval for Prevention of Heart Attack in Patients Undergoing PCI

February 23, 2009 - Daiichi Sankyo Co. Ltd and Eli Lilly and Co. announced today that the European Commission granted marketing authorization for EFFIENT (prasugrel) for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing PCI.

Prasugrel reportedly works by reducing the tendency of platelets, the blood particles responsible for clotting, from sticking or clumping together. By blocking a specific receptor (P2Y12 adenosine diphosphate) on the platelet surface, prasugrel prevents platelets from clumping, which can result in clogged arteries and may lead to heart attack.

In a large Phase III study, prasugrel was superior to Plavix/Iscover (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 FDA is currently evaluating prasugrel for use in the U.S.

(1) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed December 9, 2008.

(2) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.final.pdf. Accessed December 9, 2008.

(3) WebMD Medical Reference in Collaboration with the Cleveland Clinic. Heart Disease: Coronary Artery Disease. http://www.webmd.com/heart-disease/guide/heart-disease-coronary-artery-disease. Accessed December 9, 2008.

For more information: www.daiichisankyo.com.