Advisory Committee Will Evaluate Prasugrel

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will decide today whether to recommend approval of Eli Lilly and Daiichi Sankyo’s prasugrel for acute coronary syndrome and whether to recommend it to reduce the incidence of stent thrombosis, despite the risk of bleeding. Prasugrel was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use last December. It will be marketed in Europe as Efient if approved by the European Commission. The advisory committee also will examine a possible link between prasugrel and cancer.
Drug Industry Daily