Heart Disease
European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
Published in FDA Law Weekly, March 12th, 2009
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 (NYSE:LLY) announced that the European Commission has granted marketing authorization for EFIENT(R) (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...
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Source: FDA Law Weekly (2009-03-12)
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