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European Commission Approves Prasugrel for Patients With Acute Coronary Syndrome Undergoing PCI
The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on December 18, 2008.
"This European approval is good news for doctors and patients since more than 700,000 people die from heart attacks in the European Union each year," said Takashi Shoda, president and chief executive officer of Daiichi Sankyo Co., Ltd. "We believe Efient will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences."
Prasugrel 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.
"The approval of Efient helps to meet an important medical need. Survivors of heart attacks have a substantial risk of suffering from one or more additional heart attacks," said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. "This action is a major step forward in giving healthcare professionals and patients in European countries a new antiplatelet option for treating ACS."
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. In addition, ACS affects nearly 1.5 million people in the United States annually. Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS.(3) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.
Source: Daiichi Sankyo Company and Eli Lilly and Company