The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel from Daiichi Sankyo and Eli Lilly for the prevention of atherothrombotic events in patients with acute coronary syndromes undergoing PCI.
The CHMP’s positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation.
If the drug is approved, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name Efient, according to the Indianapolis-based Lilly and the Toyko-based Daiichi.
The companies said their submission package contains data from trials, including TRITON-TIMI 38, a head-to-head study that evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix) in reducing atherothrombotic events in 13,608 patients with acute coronary syndromes undergoing PCI. These data were presented at the American Heart Association (AHA) Scientific Sessions and simultaneously published in the New England Journal of Medicine in November 2007.