Briefs: Boehringer files Pradaxa for DVT and PE; Astellas' Mycamine pediatric approval; Simcere divests Boda

Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines Agency) for use of Pradaxa (dabigatran etexilate) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE. Rival drug Xarelto (rivaroxaban), from Germany’s Bayer, gained European approval for DVT and PE last year (The Pharma Letter November 21, 2012).

The EMA submission is based on the results of four global Phase III studies investigating the efficacy and safety of Pradaxa in the treatment of acute DVT and PE and in secondary prevention of recurrent DVT and PE. In these studies, Pradaxa was proven to be as effective as warfarin, with lower rates of clinically relevant bleeding (which includes major bleeding) and total bleeding for patients with DVT or PE. When compared to placebo, Pradaxa prevented nine out of 10 episodes of recurrent DVT and PE.

Pradaxa is already widely approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement and total knee replacement surgery.