EC approves Boeh Ing's Pradaxa in VTE

The European Commission has granted marketing authorization to Boehringer Ingelheim's oral direct thrombin inhibitor, Pradaxa (dabigatran etexilate), in all 27 European Union member states. The German drug major plans to lauch the agent in its domestic market and the UK in the coming weeks.

The drug is approved for the prevention of venous thromboembolic events in adults after total hip or total knee replacement surgery. This places it ahead of its main competitor, Bayer Schering/Johnson & Johnson's Xarelto (rivaroxaban) which was submitted to the European Medicines Agency (EMEA) in October 2007 for the prevention of VTE after major orthopedic surgery of the lower limbs.

The marketplace for anti-clotting drugs is currently dominated by Sanofi-Aventis' blockbuster injectable anti-thrombotic Lovenox (enoxaparin). The drug earned 674.0 million euros ($1.04 billion) in fourth-quarter 2007. As once-daily pills, Pradaxa and Xarelto have a clear advantage over the current standard treatment, but the head start could be important to Boehringer as, in clinical studies, the Bayer drug was 65% more effective than Lovenox while Pradaxa showed only comparable efficacy (Marketletter September 24, 2007).