Heart patients with acute coronary syndrome (ACS) undergoing an artery-opening procedure will soon have a new treatment option to help prevent heart attacks. Daiichi Sankyo Company, Limited and Eli Lilly and Company announced that the European Commission (EC) has granted marketing authorization for Efient (pronounced Ef-ee-ent) (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (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, 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/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 per cent incidence) compared with clopidogrel (1.7 per cent 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 US 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.
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. as a treatment initially for patients with acute coronary syndromes who are undergoing PCI.