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news.Boehringer Ingelheim has announced that the European Commission has granted marketing authorization of the novel, oral direct thrombin inhibitor, Pradaxa in all 27 EU member states.
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It is anticipated that Pradaxa will be launched in Germany and the UK in the coming weeks. Pradaxa is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
The standard recommended dosage of Pradaxa is a fixed oral dose of 220mg given once daily. A second approved dosage of 150mg taken as two capsules of 75mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.
Andreas Barner, member of the board of Boehringer Ingelheim, said: “We remain confident in the potential for Pradaxa to satisfy the unmet medical needs of even more patients and physicians in the future as we continue to invest in our extensive RE-VOLUTION clinical trial program investigating Pradaxa across four further therapeutic areas.”