FDA accepts Trigen's TGN-255 IND

German drug developer Trigen says that the US Food and Drug Administration has accepted an Investigational New Drug application relating to its developmental thrombin inhibitor flovagatran (formerly TGN 255). The firm added that the results of a previously-completed Phase II trial indicated that the agent is effective in preventing blood clot formation during hemodialysis.

Trigen said that the Phase III program will consist of three randomized, multicenter studies which will examine the safety and efficacy of the drug relative to current standard treatments, in patients who can receive heparin as well as in those with heparin-induced thrombocytopenia.