Daiichi and Lilly File Prasugrel Marketing Authorization Application
Posted on: Wednesday, 20 February 2008, 12:00 CST
Daiichi Sankyo and Eli Lilly and Company have reported that they have submitted a marketing authorization application or MAA to the European Medicines Agency for the prevention of atherothrombotic events in patients with acute coronary syndrome managed with percutaneous coronary intervention.
The MAA submission is based upon data from several trials, including the landmark TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel in reducing atherothrombotic events (combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke) in 13,608 patients with acute coronary syndrome managed with percutaneous coronary intervention.
John Alexander, global head of R&D, Daiichi Sankyo, said: "This MAA submission for prasugrel represents a significant step toward achieving regulatory approval to make this important new treatment option available for patients throughout Europe."
Source: Datamonitor
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