Indianapolis, IN - The European Commission today granted marketing approval of prasugrel (Lilly/Daiichi Sankyo) for the prevention of atherothrombotic events in patients with ACS undergoing PCI [1].

The European approval follows the recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which gave its positive opinion on December 18, 2008.

The approval is based largely on the pivotal Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON-TIMI 38). As previously reported by heartwire, the TRITON study showed that prasugrel significantly reduced ischemic events compared with clopidogrel, but at the expense of an increase in major bleeding in ACS patients scheduled for PCI.

Prasugrel will be marketed in Europe as Efient.

Although the European approval comes first, a positive nod from the US Food and Drug Administration is expected soon. On February 3, 2009, the Cardiovascular and Renal Drugs Advisory Committee voted unanimously, but not without controversy, to recommend approval of prasugrel for the treatment of ACS. Although not obligated to follow the advisory panel's recommendations, the agency usually does.