Germany’s Boehringer Ingelheim has received marketing authorisation from the European Commission for its blood clot drug Pradaxa, thus stealing a march on Bayer’s rival experimental drug Xarelto.
Boehringer notes that Pradaxa (dabigatran etexilate), an oral direct thrombin inhib
itor, has been approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery. The company says that it plans to launch the product in Germany and UK in the coming weeks.
Andreas Barner, responsible for R&D at
Boehringer, said that this first licence for Pradaxa “marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi”. He added that the firm remains confident in the potential for the drug which is also being investigated in Boehringer’s extensive RE-VOLUTION clinical trial programme “across four further therapeutic areas.” RE-VOLUTION involves more than 34,000 patients worldwide and one of the programmes is looking at the prevention of cardiac events in patients with acute coronary syndrome.
Bengt Eriksson of the University Hospital Sahlgrenska/Ostra in Gothenburg, Sweden said that “for many years, there has been a need for an effective oral anticoagulant with a good safety profile to enable convenient thromboprophylaxis management in and out of the hospital environment”. Now, following the approval of Pradaxa, “we will have an attractive alternative to other thromboprophylaxis regimens to protect our patients from VTE”, he added.
Pradaxa is going into a market that it currently dominated by Sanofi-Aventis’ Lovenox but Boehringer’s pill is more convenient than the French firm’s injection. The Commission’s approval also means that Pradaxa has beaten Bayer’s Xarelto (rivaroxaban) to market.
