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Marketing authorisation for Boehringer

Boehringer Ingelheim announced on March 27 that marketing authorisation has been granted for its drug Pradaxa

Boehringer Ingelheim announced on March 27 that marketing authorisation has been granted for its drug Pradaxa.

Pradaxa, a oral direct thrombin inhibitor, has been developed and approved for the prevention of postoperative venous thromboembolic events.

Dr Andreas Barner, member of Boehringer's board and responsible for research, development, and medicine, said: "This first licence for our novel oral anticoagulant Pradaxa marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi (blood clots)."

"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 existence RE-VOLUTION clinical trail programme investigating Pradaxa across further therapeutic areas," he added.

Pradaxa is approved for adults who have undergone hip or knee replacement surgery and will be launched in Germany and the UK in the coming weeks.

Dr Bengt Eriksson, principal investigator of RE-NOVATE and RE-MODEL studies, department of orthopaedic surgery at the University Hospital Sahlgrenska, Sweden, said: "The risk of potentially life-threatening thrombosis is a major concern following major orthopaedic surgery."

"Following the approval of Pradaxa, we will have an attractive alternative to other thromboprophylaxis regimens to protect our patients from venous thromboembolism (VTE)," he added.

27th March 2008

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