The European Commission has granted Eli Lilly and Daiichi Sankyo marketing authorization for Efient (prasugrel) for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing PCI.
The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency on Dec. 18, 2008.
In a TRITON-TIMI Phase III trial, prasugrel was superior to Plavix (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 major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence).
Daiichi Sankyo and Eli Lilly co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner Ube Industries, as a treatment initially for patients with ACS, who are undergoing PCI.
While the FDA has yet to make a final decision on the blood thinner, an FDA advisory panel voted 9 to 0 to recommend prsugrel treatment for patients with ACS. The FDA usually, but not always, follows such recommendations.