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.”