Pradaxa Ph III stroke program nears end

German drug major Boehringer Ingelheim says that the last patient has completed treatment in the RE-LY study. The landmark Phase III trial is  comparing the long-term efficacy and safety of its novel, oral direct  thrombin inhibitor Pradaxa (dabigatran etexilate) with the current  standard therapy, warfarin, for the prevention of stroke and systemic  embolism in patients with atrial fibrillation.

The agent is the most advanced oral anticoagulant in development in  this indication, which places the Boehringer oral direct thrombin  inhibitor ahead of its closest rival, Bayer's Xarelto (rivaroxaban), an  oral Factor Xa blocker.

RE-LY, the largest stroke prevention in AF trial to date, enrolled  18,113 patients, in over 900 centers in 44 countries worldwide between  December 2005 and December 2007.